Product information for all dosage forms of TYLENOL Sinus have been combined under this heading.

DESCRIPTION

Each TYLENOL® Sinus Day Non-Drowsy Gelcap or Caplet contains acetaminophen 500 mg and pseudoephedrine HCl 30 mg. Each TYLENOL® Sinus Night Time Caplet contains acetaminophen 500 mg, doxylamine succinate 6.25 mg and pseudoephedrine HCl 30 mg. Each Tylenol Sinus Severe Congestion Caplet with Cool Burst™ contains acetaminophen 325 mg, guaifenesin 200 mg, and pseudoephedrine HCl 30 mg.

ACTIONS

TYLENOL® Sinus Day Non-Drowsy contains a clinically proven analgesic-antipyretic and a decongestant. Maximum allowable non-prescription levels of acetaminophen and pseudoephedrine provide temporary relief of sinus pain and headache and congestion. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and aspirin-containing products. Acetaminophen produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating center. Pseudoephedrine hydrochloride is a sympathomimetic amine which promotes sinus cavity drainage by reducing nasopharyngeal mucosal congestion.

TYLENOL® Sinus Night Time Caplets contain, in addition to the above ingredients, an antihistamine which provides temporary relief of runny nose and itching of the nose or throat.

Tylenol® Sinus Severe Congestion with Cool Burst™ contains a clinically proven analgesic-antipyretic, an expectorant, and a decongestant. Maximum allowable non-prescription levels of acetaminophen, guaifenesin, and pseudoephedrine HCl provide temporary relief of sinus pain, headache, and congestion. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and its unlikely to produce many of the side effects associated with aspirin and aspirin-containing products. Acetaminophen produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating center. Guaifenesin is an expectorant which helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. Pseudoephedrine hydrochloride is a sympathomimetic amine which promotes sinus cavity drainage by reducing nasopharyngeal mucosal congestion.

USES

TYLENOL® Sinus Day Non-Drowsy Caplet: temporarily relieves:

sinus pain · headache · nasal and sinus congestion

TYLENOL® Sinus Day Non-Drowsy Gelcap:

temporarily relieves:
- sinus congestion and pressure · headache
temporarily relieves nasal congestion due to hay fever and other upper respiratory allergies

TYLENOL® Sinus Night Time: temporarily relieves:

nasal congestion · sinus pressure · sinus pain · headache · runny nose · sneezing · itchy, watery eyes · itching of the nose or throat

Tylenol® Sinus Severe Congestion with Cool Burst™ temporarily relieves:

minor aches and pains
sinus headache
temporarily relieves nasal congestion associated with sinusitis
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

DIRECTIONS

TYLENOL® Sinus Day Non-Drowsy:

do not take more than directed (see overdose warning )


adults and children 12 years and over	·take 2 Gelcaps or Caplets every 4-6 hours as needed ·do not take more than 8 Gelcaps or Caplets in 24 hours
children under 12 years	·do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

TYLENOL® Sinus Night Time:

do not take more than directed (see overdose warning )


adults and children 12 years and over	·take 2 caplets every 4-6 hours as needed ·do not take more than 8 caplets in 24 hours
children under 12 years	·do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Tylenol® Sinus Severe Congestion with Cool Burst™

Do not take more than directed (see overdose warning )


adults and children 12 years and over	·take 2 caplets every 4-6 hours as needed ·swallow whole--do not crush, chew or dissolve · do not take more than 8 caplets in 24 hours
children under 12 years	·do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

WARNINGS

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use

if you are now taking a prescription monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
with any other product containing acetaminophen

Ask a doctor before use if you have

TYLENOL® Sinus Day Non-Drowsy Gelcaps and Caplets

heart disease · high blood pressure
thyroid disease · diabetes
trouble urinating due to an enlarged prostate gland

TYLENOL® Sinus Night Time Caplets

heart disease · glaucoma · diabetes
thyroid disease · high blood pressure
trouble urinating due to an enlarged prostate gland · a breathing problem such as emphysema or chronic bronchitis

TYLENOL® Sinus Severe Congestion Caplet with Cool Burst™

heart disease · diabetes · thyroid disease
cough that occurs with too much phlegm (mucus)
high blood pressure · trouble urinating due to an enlarged prostate gland · chronic cough that lasts as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers ( TYLENOL® Sinus Nighttime Caplet only)

When using this product

TYLENOL® Sinus Caplet Day Non-Drowsy Caplets and TYLENOL® Sinus Severe Congestion Caplets with Cool Burst™

do not exceed recommended dosage

TYLENOL® Sinus Nighttime Caplets

do not exceed recommended dosage
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if

TYLENOL® Sinus Day Non-Drowsy Caplets and TYLENOL® Sinus Nighttime Caplets

new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 7 days
fever gets worse or lasts for more than 3 days
you get nervous, dizzy or sleepless

TYLENOL® Sinus Day Non-Drowsy Gelcaps

new symptoms occur
redness or swelling is present
pain or nasal congestion gets worse or lasts for more than 7 days
fever gets worse or lasts for more than 3 days
you get nervous, dizzy or sleepless

TYLENOL® Sinus Severe Congestion Caplets with Cool Burst™

new symptoms occur
redness or swelling is present
pain, nasal congestion, or cough gets worse or lasts for more than 7 days
you get nervous, dizzy or sleepless
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

each caplet contains: sodium 3 mg ( TYLENOL® Sinus Severe Congestion Caplet only)
do not use if carton is opened or if blister unit is broken

TYLENOL® Sinus Gelcaps

store between 20-25°C (68-77°F); avoid high humidity

TYLENOL® Sinus Caplets and TYLENOL® Sinus Night Time Caplets

store at room temperature

Tylenol® Sinus Severe Congestion Caplets with Cool Burst™

Store between 20-25° C (68-77° F)
see side panel for lot number and expiration date

PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATION

For overdosage information, please refer to pgs. ___ - ___.

Inactive Ingredients:

TYLENOL® Sinus Day Non-Drowsy Formula: Caplets: carnauba wax, cellulose, corn starch, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide.

Gelcaps: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, D&C Yellow #10, edetate calcium disodium, FD&C Blue #1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

TYLENOL® Sinus Night Time Caplets: black iron oxide, carnauba wax, cellulose, corn starch, FD&C Blue #1, FD&C Blue #2, hypromellose, propylene glycol, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin, yellow iron oxide.

Tylenol® Sinus Severe Congestion with Cool Burst™ Caplet: cellulose, corn starch, croscarmellose sodium, D&C yellow #10, FD&C blue #1, FD&C red #40, flavor, iron oxide, mannitol, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

HOW SUPPLIED

TYLENOL® Sinus Day Non-Drowsy Formula:

Caplets: Light green-colored, imprinted with "TYLENOL Sinus" in green ink--blister packs of 24 and 48.

Gelcaps: Green- and white-colored, imprinted with "TYLENOL Sinus" in dark green ink--blister packs of 24 and 48.

TYLENOL® Sinus Night Time Caplets: Green-colored, imprinted with "Tylenol Sinus NT"--blister packs of 24.

These products are also available in a convenience pack containing TYLENOL® Sinus Day Non-Drowsy (pack of 12) and TYLENOL® Sinus Night Time (pack of 12).

Tylenol® Sinus Severe Congestion with Cool Burst™ are light green-colored caplets printed with "Tylenol Sinus SC" in black ink and are available in blister packs of 12, 24, and 48.

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.