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Name:Advil Congestion Relief
Manufacturer:Pfizer Consumer Healthcare
Category:Over-the-counter (OTC) Marketed Drugs


Advil Congestion Relief[Ibuprofen and Phenylephrine HCl]

ADVIL CONGESTION RELIEF - ibuprofen and phenylephrine hydrochloride tablet, film coated 
Pfizer Consumer Healthcare

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Advil Congestion Relief
[Ibuprofen and Phenylephrine HCl]

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

* nonsteroidal anti-inflammatory drug

PURPOSES

Pain reliever/fever reducer

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
  • blisters

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

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 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 toll free at 1-800-88-ADVIL

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CONTAINS: Ibuprofen & Phenylephrine

See new warnings information

Advil CONGESTION RELIEF

Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)

Phenylephrine HCl 10 mg Nasal Decongestant

NON-DROWSY relief of: Sinus Pressure, Nasal Swelling & Congestion, and Headache

1 PILL DOSAGE

20 COATED TABLETS

NON-DROWSY

Pfizer, Madison, NJ 07940 USA © 2010 Pfizer Inc.

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

Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken.

../images_otc/advil_conges_PAA012149.jpg

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

LIFT HERE For More Drug Facts

../images_otc/advil_conges_PAA012221.jpg

ADVIL CONGESTION RELIEF 
ibuprofen, phenylephrine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0195
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
acesulfame potassium  
carnauba wax  
colloidal silicon dioxide  
croscarmellose sodium  
ferrous oxide  
glycerin  
hypromelloses  
lactic acid  
lecithin, soybean  
maltodextrin  
medium-chain triglycerides  
polydextrose  
polyvinyl alcohol  
propyl gallate  
stearic acid  
sodium lauryl sulfate  
starch, corn  
sucralose  
talc  
titanium dioxide  
triacetin  
xanthan gum  
Product Characteristics
Color BROWN (slightly, glossy tan) Score no score
Shape OVAL (oval shaped tablet) Size 15mm
Flavor Imprint Code 1200;P10
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0573-0195-10 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 10 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (0573-0195-10)
2 NDC:0573-0195-20 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 10 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (0573-0195-20)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022565 10/04/2010

Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company, Consumer Site 829390975 MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 12/2010 Pfizer Consumer Healthcare



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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