Motrin Cold & Sinus Caplets (McNeil Consumer)

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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:

· headache · nasal congestion

· fever · minor body aches and pains

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)

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.

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