Brand Names

& Canadian product does not contain Homatropine.

Category

• Antihistaminic (H ₁ -receptor)-antitussive--Bromodiphenhydramine and Codeine; Chlorpheniramine and Dextromethorphan; Chlorpheniramine and Hydrocodone; Phenyltoloxamine and Hydrocodone; Promethazine and Codeine; Promethazine and Dextromethorphan; Pyrilamine and Codeine
• Antihistaminic (H ₁ -receptor)-antitussive-analgesic--Chlorpheniramine, Dextromethorphan, and Acetaminophen
• Antihistaminic (H ₁ -receptor)-antitussive-expectorant--Bromodiphenhydramine, Diphenhydramine, Codeine, Ammonium Chloride, and Potassium Guaiacolsulfonate; Diphenhydramine, Codeine, and Ammonium Chloride; Diphenhydramine, Dextromethorphan, and Ammonium Chloride; Pheniramine, Codeine, and Guaifenesin; Pheniramine, Pyrilamine, Hydrocodone, Potassium Citrate, and Ascorbic Acid; Promethazine, Codeine, and Potassium Guaiacolsulfonate
• Antihistaminic (H ₁ -receptor)-decongestant-antitussive--Brompheniramine, Phenylephrine, Phenylpropanolamine, and Codeine; Brompheniramine, Phenylephrine, Phenylpropanolamine, and Dextromethorphan; Brompheniramine, Phenylpropanolamine, and Codeine; Brompheniramine, Phenylpropanolamine, and Dextromethorphan; Brompheniramine, Pseudoephedrine, and Dextromethorphan; Carbinoxamine, Pseudoephedrine, and Dextromethorphan; Chlorpheniramine, Ephedrine, Phenylephrine, and Carbetapentane; Chlorpheniramine, Phenylephrine, and Dextromethorphan; Chlorpheniramine, Phenylephrine, and Hydrocodone; Chlorpheniramine, Phenylephrine, Phenylpropanolamine, and Codeine; Chlorpheniramine, Phenylephrine, Phenylpropanolamine, and Dextromethorphan; Chlorpheniramine, Phenylephrine, Phenylpropanolamine, and Dihydrocodeine; Chlorpheniramine, Phenylpropanolamine, and Caramiphen; Chlorpheniramine, Phenylpropanolamine, and Dextromethorphan; Chlorpheniramine, Pseudoephedrine, and Codeine; Chlorpheniramine, Pseudoephedrine, and Dextromethorphan; Chlorpheniramine, Pseudoephedrine, and Hydrocodone; Pheniramine, Phenylephrine, and Dextromethorphan; Pheniramine, Pyrilamine, Phenylephrine, Phenylpropanolamine, and Hydrocodone; Pheniramine, Pyrilamine, Phenylpropanolamine, and Codeine; Pheniramine, Pyrilamine, Phenylpropanolamine, and Dextromethorphan; Pheniramine, Pyrilamine, Phenylpropanolamine, and Hydrocodone; Promethazine, Phenylephrine, and Codeine; Pyrilamine, Phenylephrine, and Codeine; Pyrilamine, Phenylephrine, and Dextromethorphan; Pyrilamine, Phenylephrine, and Hydrocodone; Triprolidine, Pseudoephedrine, and Codeine; Triprolidine, Pseudoephedrine, and Dextromethorphan
• Antihistaminic (H ₁ -receptor)-decongestant-antitussive-analgesic--Chlorpheniramine, Phenindamine, Phenylephrine, Dextromethorphan, Acetaminophen, Salicylamide, Caffeine, and Ascorbic Acid; Chlorpheniramine, Pheniramine, Pyrilamine, Phenylephrine, Hydrocodone, Salicylamide, Caffeine, and Ascorbic Acid; Chlorpheniramine, Phenylephrine, Dextromethorphan, Acetaminophen, and Salicylamide; Chlorpheniramine, Phenylephrine, Hydrocodone, Acetaminophen, and Caffeine; Chlorpheniramine, Phenylpropanolamine, Dextromethorphan, and Acetaminophen; Chlorpheniramine, Phenylpropanolamine, Dextromethorphan, and Aspirin; Chlorpheniramine, Pseudoephedrine, Dextromethorphan, and Acetaminophen; Chlorpheniramine, Pseudoephedrine, Dextromethorphan, Acetaminophen, and Caffeine; Diphenhydramine, Pseudoephedrine, Dextromethorphan, and Acetaminophen; Doxylamine, Phenylpropanolamine, Dextromethorphan and Aspirin; Doxylamine, Pseudoephedrine, Dextromethorphan, and Acetaminophen; Pheniramine, Pyrilamine, Phenylpropanolamine, Codeine, Acetaminophen, and Caffeine; Pyrilamine, Phenylpropanolamine, Dextromethorphan, and Sodium Salicylate; Pyrilamine, Pseudoephedrine, Dextromethorphan, and Acetaminophen
• Antihistaminic (H ₁ -receptor)-decongestant-antitussive-expectorant--Brompheniramine, Phenylephrine, Phenylpropanolamine, Codeine, and Guaifenesin; Brompheniramine, Phenylephrine, Phenylpropanolamine, Hydrocodone, and Guaifenesin; Chlorpheniramine, Ephedrine, Phenylephrine, Dextromethorphan, Ammonium Chloride, and Ipecac; Chlorpheniramine, Phenylephrine, Codeine, and Ammonium Chloride; Chlorpheniramine, Phenylephrine, Codeine, and Potassium Iodide; Chlorpheniramine, Phenylephrine, Dextromethorphan, and Guaifenesin; Chlorpheniramine, Phenylephrine, Dextromethorphan, Guaifenesin, and Ammonium Chloride; Chlorpheniramine, Phenylephrine, Phenylpropanolamine, Carbetapentane, and Potassium Guaiacolsulfonate; Chlorpheniramine, Phenylpropanolamine, Dextromethorphan, and Ammonium Chloride; Chlorpheniramine, Phenyltoloxamine, Ephedrine, Codeine, and Guaiacol Carbonate; Pheniramine, Phenylephrine, Phenylpropanolamine, Hydrocodone, and Guaifenesin; Pheniramine, Pyrilamine, Phenylpropanolamine, Dextromethorphan, and Ammonium Chloride; Pheniramine, Pyrilamine, Phenylpropanolamine, Dextromethorphan, and Guaifenesin; Pheniramine, Pyrilamine, Phenylpropanolamine, Hydrocodone, and Guaifenesin; Promethazine, Phenylephrine, Codeine, and Potassium Guaiacolsulfonate; Pyrilamine, Phenylephrine, Hydrocodone, and Ammonium Chloride; Pyrilamine, Phenylpropanolamine, Dextromethorphan, Guaifenesin, Potassium Citrate, and Citric Acid; Triprolidine, Pseudoephedrine, Codeine, and Guaifenesin
• Antihistaminic (H ₁ -receptor)-decongestant-antitussive-expectorant-analgesic--Chlorpheniramine, Phenylephrine, Phenylpropanolamine, Dextromethorphan, Guaifenesin, and Acetaminophen; Chlorpheniramine, Phenylpropanolamine, Codeine, Guaifenesin, and Acetaminophen; Pheniramine, Phenylephrine, Codeine, Sodium Citrate, Sodium Salicylate, and Caffeine
• Antihistaminic (H ₁ -receptor)-decongestant-expectorant--Brompheniramine, Phenylephrine, Phenylpropanolamine, and Guaifenesin; Chlorpheniramine, Ephedrine, and Guaifenesin; Chlorpheniramine, Phenylephrine, and Guaifenesin; Chlorpheniramine, Phenylpropanolamine, and Guaifenesin; Chlorpheniramine, Phenylpropanolamine, Guaifenesin, Sodium Citrate, and Citric Acid; Chlorpheniramine, Pseudoephedrine, and Guaifenesin; Dexchlorpheniramine, Pseudoephedrine, and Guaifenesin; Pheniramine, Pyrilamine, Phenylpropanolamine, and Guaifenesin; Promethazine, Phenylephrine, and Potassium Guaiacolsulfonate
• Antitussive-analgesic--Dextromethorphan and Acetaminophen
• Antitussive-anticholinergic--Hydrocodone and Homatropine
• Antitussive-expectorant--Codeine and Calcium Iodide; Codeine and Guaifenesin; Codeine and Iodinated Glycerol; Codeine, Ammonium Chloride, and Guaifenesin; Dextromethorphan and Guaifenesin; Dextromethorphan and Iodinated Glycerol; Hydrocodone and Guaifenesin; Hydrocodone and Potassium Guaiacolsulfonate; Hydromorphone and Guaifenesin
• Decongestant-antitussive--Phenylephrine and Codeine; Phenylephrine and Hydrocodone; Phenylpropanolamine and Caramiphen; Phenylpropanolamine and Dextromethorphan; Phenylpropanolamine and Hydrocodone; Pseudoephedrine and Codeine; Pseudoephedrine and Dextromethorphan; Pseudoephedrine and Hydrocodone
• Decongestant-antitussive-analgesic--Phenylpropanolamine, Dextromethorphan, and Acetaminophen; Pseudoephedrine, Dextromethorphan, and Acetaminophen
• Decongestant-antitussive-expectorant--Phenylephrine, Dextromethorphan, and Guaifenesin; Phenylephrine, Hydrocodone, and Guaifenesin; Phenylephrine, Phenylpropanolamine, Carbetapentane, and Potassium Guaiacolsulfonate; Phenylpropanolamine, Codeine, and Guaifenesin; Phenylpropanolamine, Dextromethorphan, and Guaifenesin; Pseudoephedrine, Codeine, and Guaifenesin; Pseudoephedrine, Dextromethorphan, and Guaifenesin; Pseudoephedrine, Hydrocodone, and Guaiacolsulfonate; Pseudoephedrine, Hydrocodone, and Guaifenesin
• Decongestant-antitussive-expectorant-analgesic--Phenylpropanolamine, Hydrocodone, Guaifenesin, and Salicylamide; Pseudoephedrine, Dextromethorphan, Guaifenesin, and Acetaminophen
• Decongestant-expectorant--Ephedrine and Guaifenesin; Ephedrine and Potassium Iodide; Phenylephrine and Guaifenesin; Phenylephrine, Phenylpropanolamine, and Guaifenesin; Phenylpropanolamine and Guaifenesin; Pseudoephedrine and Guaifenesin
• Decongestant-expectorant-analgesic--Phenylephrine, Guaifenesin, Acetaminophen, Salicylamide, and Caffeine

Description

Cough/cold combinations are used mainly to relieve the cough due to colds, influenza, or hay fever. They are not to be used for the chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (pronounced flem) with the cough.

Cough/cold combination products contain more than one ingredient. For example, some products may contain an antihistamine, a decongestant, and an analgesic, in addition to a medicine for coughing. If you are treating yourself, it is important to select a product that is best for your symptoms. Also, in general, it is best to buy a product that includes only those medicines you really need. If you have questions about which product to buy, check with your pharmacist.

Since different products contain ingredients that will have different precautions and side effects, it is important that you know the ingredients of the medicine you are taking. The different kinds of ingredients that may be found in cough/cold combinations include:

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Antihistamines--Antihistamines are used to relieve or prevent the symptoms of hay fever and other types of allergy. They also help relieve some symptoms of the common cold, such as sneezing and runny nose. They work by preventing the effects of a substance called histamine, which is produced by the body. Some examples of antihistamines contained in these combinations are: bromodiphenhydramine (broe-moe-dye-fen-HYE-dra-meen), brompheniramine (brome-fen-EER-a-meen), carbinoxamine (kar-bi-NOX-a-meen), chlorpheniramine (klor-fen-EER-a-meen), dexchlorpheniramine (dex-klor-fen-EER-a-meen), diphenhydramine (dye-fen-HYE-dra-meen), doxylamine (dox-ILL-a-meen), phenindamine (fen-IN-da-meen), pheniramine (fen-EER-a-meen), phenyltoloxamine (fen-ill-tole-OX-a-meen), pyrilamine (peer-ILL-a-meen), promethazine (proe-METH-a-zeen), and triprolidine (trye-PROE-li-deen).

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Decongestants--Decongestants, such as ephedrine (e-FED-rin), phenylephrine (fen-ill-EF-rin), phenylpropanolamine (fen-ill-proe-pa-NOLE-a-meen), and pseudoephedrine (soo-doe-e-FED-rin), produce a narrowing of blood vessels. This leads to clearing of nasal congestion. However, this effect may also increase blood pressure in patients who have high blood pressure.

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Antitussives--To help relieve coughing these combinations contain either a narcotic [codeine (KOE-deen), dihydrocodeine (dye-hye-droe-KOE-deen), hydrocodone (hye-droe-KOE-done) or hydromorphone (hye-droe-MOR-fone)] or a nonnarcotic [carbetapentane (kar-bay-ta-PEN-tane), caramiphen (kar-AM-i-fen), or dextromethorphan (dex-troe-meth-OR-fan)] antitussive. These antitussives act directly on the cough center in the brain. Narcotics may become habit-forming, causing mental or physical dependence, if used for a long time. Physical dependence may lead to withdrawal side effects when you stop taking the medicine.

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Expectorants--Guaifenesin (gwye-FEN-e-sin) works by loosening the mucus or phlegm in the lungs. Other ingredients added as expectorants (for example, ammonium chloride, calcium iodide, iodinated glycerol, ipecac, potassium guaiacolsulfonate, potassium iodide, and sodium citrate) have not been proven to be effective. In general, the best thing you can do to loosen mucus or phlegm is to drink plenty of water.

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Analgesics--Analgesics, such as acetaminophen (a-seat-a-MIN-oh-fen), aspirin, and other salicylates [such as salicylamide (sal-i-SILL-a-mide) and sodium salicylate (SOE-dee-um sa-LI-sill-ate)] are used in these combination medicines to help relieve the aches and pain that may occur with the common cold.

The use of too much acetaminophen and salicylates at the same time may cause kidney damage or cancer of the kidney or urinary bladder. This may occur if large amounts of both medicines are taken together for a long time. However, taking the recommended amounts of combination medicines that contain both acetaminophen and a salicylate for short periods of time has not been shown to cause these unwanted effects.

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Anticholinergics--Anticholinergics such as homatropine (hoe-MA-troe-peen) may help produce a drying effect in the nose and chest.

Some of these combinations are available only with your doctor's prescription. Others are available without a prescription; however, your health care professional may have special instructions on the proper dose of the medicine for your medical condition.

Cough/cold combinations are available in the following dosage forms:

Before Using This Medicine

If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For cough/cold combinations, the following should be considered:

Allergies--Tell your doctor if you have ever had any unusual or allergic reaction to any of the ingredients contained in this medicine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. In addition, if this medicine contains aspirin or other salicylates , before taking it, check with your doctor if you have ever had any unusual or allergic reaction to any of the following medicines:

• Aspirin or other salicylates
• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Fenoprofen (e.g., Nalfon)
• Floctafenine
• Flurbiprofen, by mouth (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Methyl salicylate (oil of wintergreen)
• Naproxen (e.g., Naprosyn)
• Oxyphenbutazone (e.g., Tandearil)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Suprofen (e.g., Suprol)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)
• Zomepirac (e.g., Zomax)

Diet--Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Pregnancy--The occasional use of a cough/cold combination is not likely to cause problems in the fetus or in the newborn baby. However, when these medicines are used at higher doses and/or for a long time, the chance that problems might occur may increase. For the individual ingredients of these combinations, the following information should be considered before you decide to use a particular cough/cold combination:

• Acetaminophen --Studies on birth defects have not been done in humans. However, acetaminophen has not been shown to cause birth defects or other problems in humans.
• Alcohol --Some of these combination medicines contain a large amount of alcohol. Too much use of alcohol during pregnancy may cause birth defects.
• Antihistamines --Antihistamines have not been shown to cause problems in humans.
• Caffeine --Studies in humans have not shown that caffeine causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to the amount of caffeine contained in 12 to 24 cups of coffee a day).
• Codeine --Although studies on birth defects with codeine have not been done in humans, it has not been reported to cause birth defects in humans. Codeine has not been shown to cause birth defects in animal studies, but it caused other unwanted effects. Also, regular use of narcotics during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. In addition, narcotics may cause breathing problems in the newborn baby if taken by the mother just before delivery.
• Hydrocodone --Although studies on birth defects with hydrocodone have not been done in humans, it has not been reported to cause birth defects in humans. However, hydrocodone has been shown to cause birth defects in animals when given in very large doses. Also, regular use of narcotics during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. In addition, narcotics may cause breathing problems in the newborn baby if taken by the mother just before delivery.
• Iodides (e.g., calcium iodide and iodinated glycerol) --Not recommended during pregnancy. Iodides have caused enlargement of the thyroid gland in the fetus and resulted in breathing problems in newborn babies whose mothers took iodides in large doses for a long period of time.
• Phenylephrine --Studies on birth defects with phenylephrine have not been done in either humans or animals.
• Phenylpropanolamine --Studies on birth defects with phenylpropanolamine have not been done in either humans or animals. However, it seems that women who take phenylpropanolamine in the weeks following delivery are more likely to suffer mental or mood changes.
• Pseudoephedrine --Studies on birth defects with pseudoephedrine have not been done in humans. In animal studies pseudoephedrine did not cause birth defects but did cause a decrease in average weight, length, and rate of bone formation in the animal fetus when given in high doses.
• Salicylates (e.g., aspirin) --Studies on birth defects in humans have been done with aspirin, but not with salicylamide or sodium salicylate. Salicylates have not been shown to cause birth defects in humans. However, salicylates have been shown to cause birth defects in animals.
  Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or newborn baby.
  Use of salicylates, especially aspirin, during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery, or in the newborn baby. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor .

Breast-feeding--If you are breast-feeding, the chance that problems might occur depends on the ingredients of the combination. For the individual ingredients of these combinations, the following apply:

• Acetaminophen --Acetaminophen passes into the breast milk. However, it has not been reported to cause problems in nursing babies.
• Alcohol --Alcohol passes into the breast milk. However, the amount of alcohol in recommended doses of this medicine does not usually cause problems in nursing babies.
• Antihistamines --Small amounts of antihistamines pass into the breast milk. Antihistamine-containing medicine is not recommended for use while breast-feeding since most antihistamines are especially likely to cause side effects, such as unusual excitement or irritability, in the baby. Also, since antihistamines tend to decrease the secretions of the body, the flow of breast milk may be reduced in some patients.
• Caffeine --Small amounts of caffeine pass into the breast milk and may build up in the nursing baby. However, the amount of caffeine in recommended doses of this medicine does not usually cause problems in nursing babies.
• Decongestants (e.g., ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine) --Phenylephrine and phenylpropanolamine have not been reported to cause problems in nursing babies. Ephedrine and pseudoephedrine pass into the breast milk and may cause unwanted effects in nursing babies (especially newborn and premature babies).
• Iodides (e.g., calcium iodide and iodinated glycerol) --These medicines pass into the breast milk and may cause unwanted effects, such as underactive thyroid, in the baby.
• Narcotic antitussives (e.g., codeine, dihydrocodeine, hydrocodone, and hydromorphone) --Small amounts of codeine have been shown to pass into the breast milk. However, the amount of codeine or other narcotic antitussives in recommended doses of this medicine has not been reported to cause problems in nursing babies.
• Salicylates (e.g., aspirin) --Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly.

Children--Very young children are usually more sensitive to the effects of this medicine. Before giving any of these combination medicines to a child, check the package label very carefully. Some of these medicines are too strong for use in children . If you are not certain whether a specific product can be given to a child, or if you have any questions about the amount to give, check with your health care professional, especially if it contains:

• Antihistamines --Nightmares, unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children taking antihistamines.
• Decongestants (e.g., ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine) --Increases in blood pressure may be more likely to occur in children taking decongestants. Also, mental changes may be more likely to occur in young children taking phenylpropanolamine-containing combinations.
• Narcotic antitussives (e.g., codeine, hydrocodeine, hydrocodone, and hydromorphone) --Breathing problems may be especially likely to occur in children younger than 2 years of age taking narcotic antitussives. Also, unusual excitement or restlessness may be more likely to occur in children receiving these medicines.
• Salicylates (e.g., aspirin) -- Do not give medicines containing aspirin or other salicylates to a child with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor . This is very important because salicylates may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Also, children may be more sensitive to the aspirin or other salicylates contained in some of these medicines, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.

Adolescents--Do not give medicines containing aspirin or other salicylates to a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor . This is very important because salicylates may cause a serious illness called Reye's syndrome in teenagers with fever caused by a virus infection, especially flu or chickenpox.

Older adults--The elderly are usually more sensitive to the effects of this medicine, especially if it contains:

• Antihistamines --Confusion, difficult or painful urination, dizziness, drowsiness, feeling faint, or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly taking antihistamines.
• Decongestants (e.g., ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine) --Confusion, hallucinations, drowsiness, or convulsions (seizures) may be more likely to occur in the elderly, who are usually more sensitive to the effects of this medicine. Also, increases in blood pressure may be more likely to occur in elderly persons taking decongestants.

Other medicines--Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine, for example, aspirin or other medicine for allergies. Some medicines may change the way this medicine affects your body. Also, the effect of other medicines may be increased or reduced by some of the ingredients in this medicine. Check with your health care professional about which medicines you should not take with this medicine.

Other medical problems--The presence of other medical problems may affect the use of the cough/cold combination medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of)--Acetaminophen-containing medicines increase the chance of liver damage; also, some of the liquid medicines contain a large amount of alcohol

• Anemia or
• Gout or
• Hemophilia or other bleeding problems or
• Stomach ulcer or other stomach problems--These conditions may become worse if you are taking a combination medicine containing aspirin or another salicylate

• Brain disease or injury or
• Colitis or
• Convulsions (seizures) (history of) or
• Diarrhea or
• Gallbladder disease or gallstones--These conditions may become worse if you are taking a combination medicine containing codeine, dihydrocodeine, hydrocodone, or hydromorphone

• Cystic fibrosis (in children)--Side effects of iodinated glycerol may be more likely in children with cystic fibrosis

• Diabetes mellitus (sugar diabetes)--Decongestants may put diabetic patients at greater risk of having heart or blood vessel disease

• Emphysema, asthma, or chronic lung disease (especially in children)--Salicylate-containing medicine may cause an allergic reaction in which breathing becomes difficult

• Enlarged prostate or
• Urinary tract blockage or difficult urination--Some of the effects of anticholinergics (e.g., homatropine) or antihistamines may make urinary problems worse

• Glaucoma--A slight increase in inner eye pressure may occur with the use of anticholinergics (e.g., homatropine) or antihistamines, which may make the condition worse

• Heart or blood vessel disease or
• High blood pressure--Decongestant-containing medicine may increase the blood pressure and speed up the heart rate; also, caffeine-containing medicine, if taken in large amounts, may speed up the heart rate

• Kidney disease--This condition may increase the chance of side effects of this medicine because the medicine may build up in the body

• Liver disease--Liver disease increases the chance of side effects because the medicine may build up in the body; also, if liver disease is severe, there is a greater chance that aspirin-containing medicine may cause bleeding

• Thyroid disease--If an overactive thyroid has caused a fast heart rate, the decongestant in this medicine may cause the heart rate to speed up further; also, if the medicine contains narcotic antitussives (e.g., codeine), iodides (e.g., iodinated glycerol), or salicylates, the thyroid problem may become worse

Proper Use of This Medicine

To help loosen mucus or phlegm in the lungs, drink a glass of water after each dose of this medicine , unless otherwise directed by your doctor.

Take this medicine only as directed . Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

For patients taking the extended-release capsule or tablet form of this medicine :

• Swallow the capsule or tablet whole.
• Do not crush, break, or chew before swallowing.
• If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.

For patients taking a combination medicine containing an antihistamine and/or aspirin or other salicylate :

• Take with food or a glass of water or milk to lessen stomach irritation, if necessary.

If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it . This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.

Missed dose--If you must take this medicine regularly and you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage--To store this medicine:

• Keep this medicine out of the reach of children. Overdose is very dangerous in young children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing. Do not refrigerate the syrup.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your cough has not improved after 7 days or if you have a high fever, skin rash, continuing headache, or sore throat with the cough, check with your doctor. These signs may mean that you have other medical problems.

For patients taking antihistamine-containing medicine :

• Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by the antihistamine in this medicine.
• This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine .
• This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .
• When taking antihistamines on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin at the same time (as in arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by the antihistamine.
• Antihistamines may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

For patients taking decongestant-containing medicine :

• This medicine may add to the central nervous system (CNS) stimulant and other effects of phenylpropanolamine (PPA)-containing diet aids. Do not use medicines for diet or appetite control while taking this medicine unless you have checked with your doctor .
• This medicine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime . If you have any questions about this, check with your doctor.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking narcotic antitussive (codeine, dihydrocodeine, hydrocodone, or hydromorphone)-containing medicine :

• This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine .
• This medicine may cause some people to become drowsy, dizzy, less alert than they are normally, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded .
• Nausea or vomiting may occur after taking a narcotic antitussive. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your doctor.
• Dizziness, lightheadedness, or fainting may be especially likely to occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking iodide (calcium iodide, iodinated glycerol, or potassium iodide)-containing medicine :

• Make sure your doctor knows if you are planning to have any future thyroid tests. The results of the thyroid test may be affected by the iodine in this medicine.

For patients taking analgesic-containing medicine :

• Check the label of all nonprescription (over-the-counter [OTC]), and prescription medicines you now take . If any contain acetaminophen or aspirin or other salicylates, including diflunisal or bismuth subsalicylate, be especially careful. Taking them while taking a cough/cold combination medicine that already contains them may lead to overdose. If you have any questions about this, check with your health care professional.
• Do not take aspirin-containing medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

For diabetic patients taking aspirin- or sodium salicylate-containing medicine :

• False urine sugar test results may occur:
  • If you take 8 or more 325-mg (5-grain) doses of aspirin every day for several days in a row.
  • If you take 8 or more 325-mg (5-grain), or 4 or more 500-mg (10-grain) doses of sodium salicylate.
• Smaller doses or occasional use of aspirin or sodium salicylate usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

For patients taking homatropine-containing medicine :

• This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine , since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if:

• too much medicine is taken.
• it is taken in large doses.
• it is taken for a long period of time.

Get emergency help immediately if any of the following symptoms of overdose occur :

For narcotic antitussive (codeine, dihydrocodeine, hydrocodone, or hydromorphone)-containing

Cold, clammy skin; confusion (severe); convulsions (seizures); drowsiness or dizziness (severe); nervousness or restlessness (severe); pinpoint pupils of eyes; slow heartbeat; slow or troubled breathing; weakness (severe)

For acetaminophen-containing

Diarrhea; increased sweating; loss of appetite; nausea or vomiting; stomach cramps or pain; swelling or tenderness in the upper abdomen or stomach area

For salicylate-containing

Any loss of hearing; bloody urine; confusion; convulsions (seizures); diarrhea (severe or continuing); dizziness or lightheadedness; drowsiness (severe); excitement or nervousness (severe); fast or deep breathing; fever; hallucinations (seeing, hearing, or feeling things that are not there); increased sweating; nausea or vomiting (severe or continuing); shortness of breath or troubled breathing (for salicylamide only); stomach pain (severe or continuing); uncontrollable flapping movements of the hands, especially in elderly patients; unusual thirst; vision problems

For decongestant-containing

Fast, pounding, or irregular heartbeat; headache (continuing and severe); nausea or vomiting (severe); nervousness or restlessness (severe); shortness of breath or troubled breathing (severe or continuing)

Also, check with your doctor as soon as possible if any of the following side effects occur:

For all combinations

Skin rash, hives, and/or itching

For antihistamine- or anticholinergic-containing

Clumsiness or unsteadiness; convulsions (seizures); drowsiness (severe); dryness of mouth, nose, or throat (severe); flushing or redness of face; hallucinations (seeing, hearing, or feeling things that are not there); restlessness (severe); shortness of breath or troubled breathing; slow or fast heartbeat

For iodine-containing

Headache (continuing); increased watering of mouth; loss of appetite; metallic taste; skin rash, hives, or redness; sore throat; swelling of face, lips, or eyelids

For acetaminophen-containing

Unexplained sore throat and fever; unusual tiredness or weakness; yellow eyes or skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Constipation; decreased sweating; difficult or painful urination; dizziness or lightheadedness; drowsiness; dryness of mouth, nose, or throat; false sense of well-being; increased sensitivity of skin to sun; nausea or vomiting; nightmares; stomach pain; thickening of mucus; trouble in sleeping; unusual excitement, nervousness, restlessness, or irritability; unusual tiredness or weakness

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 09/03/92
Interim revision: 08/11/95; 08/28/96; 09/28/98

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