Label: IBUPROFEN tablet, sugar coated
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Contains inactivated NDC Code(s)
NDC Code(s): 63739-134-01 - Packager: McKesson Packaging Services Business Unit of McKesson Corporation
- This is a repackaged label.
- Source NDC Code(s): 51660-420
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 3, 2009
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)
- Purpose
- Uses
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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.
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 an 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
- if you have 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 problems that last or come back, such as heartburn, upset stomach or stomach pain
- ulcers
- bleeding problems
- high blood pressure
- reached age 60 or older
- heart or kidney disease
- taken a diuretic
- asthma
Ask a doctor or pharmacist before use if you are
- 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 aspirin to prevent 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
- long term continuous use may increase the risk of heart attack or stroke
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
- stomach pain or upset gets worse or lasts
- fever gets worse or lasts more than 3 days
- redness or swelling is present in 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 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.
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Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days unless directed by a doctor (see warnings)
- adults and children 12 years of age 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
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Inactive ingredients
acacia, calcium carbonate, carnauba wax, confectioner's sugar,crospovidone, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, pregelatinized starch, silicon dioxide, sodium benzoate, starch, sucrose, talc, titanium dioxide, white wax
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PACKAGE DISPLAY PANEL
LABEL TEXT
NDC 63739-134-01
UD 750 Tablets (25X30)
Mfg. By: Ohm Laboratories, Inc. 14 Terminal Road New Brunswick, NJ 08901
Dist. By: McKesson Packaging 7101 Weddington Rd Concord, NC 28027
LS-134-01-M08-01-A-R2
FOR INSTITUTIONAL USE ONLY See window at back of box for expiration date and lot number.
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, sugar coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63739-134(NDC:51660-420) 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code 420 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63739-134-01 30 in 1 BOX, UNIT-DOSE 1 25 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA071163 01/10/2005 Labeler - McKesson Packaging Services Business Unit of McKesson Corporation (140529962)