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Ibuprofen by Western Family Foods, Inc.

Medically reviewed on October 17, 2017

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Western Family Foods, Inc.
NDC Code: 55312-219

DRUG FACTS

Active Ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain Releiver/ Fever Reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
    • temporarily reduces fever

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 an 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 oder
  • have had stomach ulders or bleeding problems
  • take blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks everyday while using this prdouct
  • take more or for a longer time than directed.

Do not use
  • if you ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic.

Ask a doctor or pharmacist before use if you are
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • 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
  • 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 stoolos
    • have stomach pain that does not bet better
    • Pain gets worse or last more than 10 days
    • Fever gets worse or last more than 3 days
    • Redness or swelling is presentin the painful area
    • any new symptoms appear

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely 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 (1-800-222-1222)

Directions
  • do not take more than directed
  • the smallest effective dose should be used
 Adults and children 12 years and older
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used.
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
 children under 12 years
  •  ask a doctor

:

Other information
  • store between 20o- 25o C (68o- 77o F)
  • read all warnings and directions before use. Keep carton
  • do not use if imprinted foil under cap is broken or missing
  • This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil®

Inactive Ingredients

colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin

Questions or comments?

Call toll free 1-503-639-6300 Monday- Friday 9AM- 5PM PST

Principal Display Panel

Ibuprofen Coated Tablets 200 mg each

Pain Reliever/ Fever Reducer (NSAID)*

Compare to the active ingredient in ADVIL®

SEE NEW WARNINGS INFORMATION

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Proudly distributed by

Western Family Foods, Inc.

P.O Box 4057, Portland, OR 97208 U.S.A

www.westernfamily.com

Manufactured by:

Granules India Limited

Madhapur, Hyderabad- 500081, INDIA

Package Labeling

Ibuprofen coated tablets 200 mg

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-219
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
DEXTROSE MONOHYDRATE 
HYPROMELLOSES 
FERRIC OXIDE RED 
LACTOSE MONOHYDRATE 
EGG PHOSPHOLIPIDS 
MALTODEXTRIN 
POVIDONE K30 
STARCH, CORN 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBROWN (reddish) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeG2
Contains    
Packaging
#Item CodePackage Description
1NDC:55312-219-202 BOTTLE (2 BOTTLE) in 1 BOX
1100 TABLET, COATED (100 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917409/01/2011
Labeler - Western Family Foods, Inc. (192166072)

 
Western Family Foods, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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