DESCRIPTION

Each MOTRIN® Cold & Sinus Caplet contains ibuprofen 200 mg and pseudoephedrine HCl 30 mg.

USES

temporarily relieves these symptoms associated with the common cold, sinusitis, or flu:

DIRECTIONS

do not take more than directed
the smallest effective dose should be used
do not take longer than 10 days, unless directed by a doctor (see Warnings)


adults and children 12 years of age and older	· take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
	· do not use more than 6 caplets in any 24-hour period unless directed by a doctor
children under 12 years of age	ask a doctor

WARNINGS

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

· hives · facial swelling · asthma (wheezing) · shock · skin reddening · rash · blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsterodial anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use

you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
you are now taking a prescription monoamine 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.

Ask a doctor before use if you have

problems or serious side effects from taking pain relievers or fever reducers
stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
ulcers
bleeding problems
high blood pressure
heart or kidney disease
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
taken a diuretic
reached age 60 or older

Ask a doctor or pharmacist before use if you are

taking any other drug containing an NSAID (prescription or nonprescription) and/or a nasal decongestant
take a blood thinning (anticoagulant) or steroid drug
taking any other product that contains ibuprofen or pseudoephedrine
under a doctor's care for any serious condition
taking any other drug

When using this product

take with food or milk if stomach upset occurs
long term continuous use may increase the risk of heart attack or stroke.

Stop use and ask a doctor if

you feel faint, vomit blood, or have bloody or block stools. These are signs of stomach bleeding.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
stomach pain or upset gets worse or lasts
redness or swelling is present in the painful area
any new symptoms appear
you get nervous, dizzy or sleepless
nasal congestion lasts for more than 7 days

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Other Information:

Carton: do not use if blister unit is broken or open
Pouch: do not use if packet is opened
Dispensit: do not use if packet is opened
store between 20-25°C (68-77°F).
avoid excessive heat above 40°C (104°F)
read all warnings and directions before use. Keep carton.
see end panel for lot number and expiration date

PROFESSIONAL INFORMATION:
OVERDOSAGE INFORMATION

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

Inactive Ingredients:

Caplets: carnauba wax, cellulose, corn starch, FD&C Red #40, hypromellose, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

HOW SUPPLIED

Caplets: (white, printed "Cold & Sinus" in red) in blister packs of 20.

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.