Label: IBUPROFEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50332-0118-4, 50332-0118-7, 50332-0118-8 - Packager: HART Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 30, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings:
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- rash
- shock
- facial swelling
- asthma (wheezing)
- skin reddening
- blisters
Stomach bleeding warning: This product contains an 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 more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or non-prescriptin NSAIDs (aspirin, ibuprofen, naproxen, or others)
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
Stop use and ask a doctor if
- an allergic reaction occurs, seek medical help right away
- fever gets worse or lasts more than 3 days
- pain gets worse or lasts more than 10 days
- redness or swelling is present in the painful area
- new symptoms occur
- you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
Do not take more than directed; the smallest effective dose should be used.
Adults and children 12 years of age and over:
- take 1 tablet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tabet, 2 tablets may be used
- do not take more than 6 tablets in 24 hours unless directed by a doctor
Children under 12 years of age: ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch*, Croscarmellose Sodium*, Hypromellose*, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol*, Polyvinyl Alcohol*, Pregelantinized Starch, Red Iron Oxide, Sodium Starch Glycolate*, Talc, Titanium Dioxide, Triacetin*.
*Contains one or more of these ingredients.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0118 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TRIACETIN (UNII: XHX3C3X673) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code IBU200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50332-0118-4 50 in 1 BOX, UNIT-DOSE 06/03/1987 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:50332-0118-7 125 in 1 BOX, UNIT-DOSE 06/03/1987 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:50332-0118-8 250 in 1 BOX, UNIT-DOSE 06/03/1987 3 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/03/1987 Labeler - HART Health (069560969)