Label: IBUPROFEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 12634-860-01, 12634-860-10, 12634-860-24 - Packager: Apotheca Inc.
- This is a repackaged label.
- Source NDC Code(s): 53746-142
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 19, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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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.
Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 NSAID (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
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ASK DOCTOR
Ask a doctor before use if you have
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- high blood pressure
- heart or kidney disease
- taken a diuretic
- reached age 60 or older
Ask a doctor before use if you are
- taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- under a doctor's care for any serious condition
- taking any other drug
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consuming 3 or more alcohol drinks per day
- WHEN USING THIS PRODUCT
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STOP USE AND ASK A DOCTOR IF
- you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- stomach pain or upset gets worse or lasts
- redness or swelling is present in the painful area
- any new symptoms appear
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
Adults and children 12 years and older - take 1 caplet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 caplet, 2 caplets may be used
- do not exceed 6 caplets in a 24-hour period, unless directed by a physician
- take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with use
- consult a physician if these symptoms are more thsn mild or if they persist
Children under 12 years - not for use
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OTHER INFORMATION
Other information
- store at 15 – 30°C (59-86°F).
Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide.
- QUESTIONS OR COMMENTS
- PACKAGE LABEL,PRINCIPAL DISPLAY PANEL,ADDITIONAL LABELS UPON REQUEST
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12634-860(NDC:53746-142) 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown (BROWN) Score no score Shape OVAL (CAPSULE-SHAPE) Size 13mm Flavor Imprint Code IP;142 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12634-860-24 24 in 1 BOTTLE, PLASTIC 2 NDC:12634-860-01 100 in 1 BOTTLE, PLASTIC 3 NDC:12634-860-10 1000 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA071333 09/16/2009 Labeler - Apotheca Inc. (051457844) Establishment Name Address ID/FEI Business Operations Apotheca Inc. 051457844 relabel, repack