Advil Cold & Sinus Caplets, Advil Cold & Sinus Tablets, Advil Cold & Sinus Liqui-Gels (Wyeth)

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Active Ingredients (in each tablet or caplet):

Ibuprofen 200 mg

Pseudoephedrine HCl 30 mg

Active Ingredients (in each LiquiGel):

Solubilized Ibuprofen equal to 200 mg ibuprofen (present as the free acid and potassium salt)

Pseudoephedrine HCl 30 mg

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

· headache · fever · nasal congestion · minor body aches and pains

Warnings:

Allergy Alert:    Ibuprofen may cause a severe allergic reaction which may include: · hives · facial swelling · asthma (wheezing) · shock

Stomach bleeding warning:    Taking more than recommended may cause stomach bleeding

Alcohol warning:    If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen may cause stomach bleeding.

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• if 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

• heart disease · high blood pressure
• thyroid disease · diabetes
• trouble urinating due to an enlarged prostate gland
• had problems or serious side effects from taking pain relievers or fever reducers
• kidney disease
• ulcers
• bleeding problems
• stomach problems that last or come back, such as heartburn, upset stomach or pain

Ask a doctor or pharmacist before use if you are

• taking any other product that contains ibuprofen or any other pain reliever/fever reducer
• taking any other product that contains pseudoephedrine or any other nasal decongestant
• under a doctor's care for any continuing medical condition
• over 65 years of age
• taking a prescription product for anticoagulation (blood thinning) or a diuretic
• taking any other drug
• taking aspirin for cardioprotection

When using this product

• do not use more than directed
• take with food or milk if stomach upset occurs

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• you get nervous, dizzy, or sleepless
• nasal congestion lasts for more than 7 days
• fever lasts for more than 3 days
• symptoms continue or get worse
• any new symptoms appear
• stomach pain occurs with use of this product or if even mild pain persists

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use this product 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 right away.

Directions:

• adults and children 12 years of age and over:
  • take 1 tablet, caplet or liqui-gel every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 tablet, caplet or liqui-gel, 2 tablets, caplets or liqui-gels may be used.
  • do not use more than 6 tablets, caplets or liqui-gels in any 24-hour period unless directed by a doctor
  • the smallest effective dose should be used
• children under 12 years of age: consult a doctor

Other Information:

• store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
• read all warnings and directions before use. Keep carton.
• each Liqui-gel contains: potassium 20 mg

Inactive Ingredients (tablets and caplets):    carnauba or equivalent wax, croscarmellose sodium, iron oxides, methylparaben, microcrystalline cellulose, propylparaben, silicon dioxide, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, sucrose, titanium dioxide

Inactive Ingredients (liqui-gels):    D&C yellow no. 10, FD&C red no. 40, fractionated coconut oil, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

How Supplied: Advil® Cold and Sinus is an oval-shaped, tan-colored caplet, a tan-colored tablet or a liqui-gel. The caplet is supplied in blister packs of 20 and 40. The tablet is available in blister packs of 20. The liqui-gel is available in blister packs of 16 and 32.

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