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ibuprofen 200 mg / phenylephrine hydrochloride 10 mg oral tablet [advil sinus congestion and pain] - 1200 p10 oval brown

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each tablet) Purposes
Ibuprofen 200 mg (NSAID)nonsteroidal anti-inflammatory drug Pain reliever/fever reducer
Phenylephrine HCl 10 mg Nasal decongestant

Uses

  • temporarily relieves these symptoms associated with the common cold or flu:
    • headache
    • fever
    • sinus pressure
    • nasal congestion
    • minor body aches and pains
  • reduces swelling of the nasal passages
  • temporarily restores freer breathing through the nose

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
  • bulers

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

Stomach bleeding warning


This product contains an NSAID, which may cause severe 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 prescription or nonprescription NSAIDs [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

  • in children under 12 years of age because this product contains too much medication for children under this age
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • 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

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking any other product that contains phenylephrine or any other nasal decongestant
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • nasal congestion lasts for more than 7 days
  • symptoms continue or get worse
  • redness or swelling is present in the painful area
  • you get nervous, dizzy, or sleepless
  • any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION


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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed
  • adults and children 12 years of age and over:
    • take 1 tablet every 4 hours while symptoms persist.
    • do not use more than 6 tablets in any 24-hour period unless directed by a doctor
  • children under 12 years of age: do not use because this product contains too much medication for children under this age

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.

Inactive Ingredients


acesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate, stearic acid, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

Questions Or Comments?


Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

Pfizer, Madison, NJ 07940 USA

For most recent product information, visit www.advil.com

Principal Display Panel - 10 Tablet Blister Pack


Advil ®

CONGESTION RELIEF

Ibuprofen 200 mg /Phenylephrine HCl 10 mg

See warnings before use.

Pfizer, Madison, NJ 07940 USA

AREA FOR EXP. & LOT

PEEL & PUSH

Principal Display Panel - 20 Tablet Blister Pack Carton


NON-DROWSY

Advil ®

CONGESTION RELIEF

Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Phenylephrine HCl 10 mg Nasal Decongestant
Relief of symptoms due to COLD or FLU
  • ✓ Nasal Congestion
  • ✓ Headache
  • ✓ Sinus Pressure
  • ✓ Fever
  • ✓ Nasal Swelling
  • ✓ Body Aches

ONEPILLDOSE!

20CoatedTablets

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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