Label: IBUPROFEN tablet, coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 55312-219-20 - Packager: Western Family Foods, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Uses
-
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
:
- Inactive Ingredients
- Questions or comments?
-
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
Manufactured by:
Granules India Limited
Madhapur, Hyderabad- 500081, INDIA
- Package Labeling
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-219 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) MALTODEXTRIN (UNII: 7CVR7L4A2D) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BROWN (reddish) Score no score Shape ROUND Size 10mm Flavor Imprint Code G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55312-219-20 2 in 1 BOX 1 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 09/01/2011 Labeler - Western Family Foods, Inc. (192166072)
