Label: REDICARE IBUPROFEN- ibuprofen 200mg tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 71105-750-68 - Packager: Redicare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 2, 2021
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- 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 ■ blisters. If an allergic reaction occurs, stop use and seek medical help right away.
Stomach Bleeding Warning: This product contains a non-steroidal 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 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 disease, liver cirrhosis, or kidney disease ■ taken a diuretic ■ reached age 60 or older
Ask a doctor or pharmacist before use if you are:
■ taking any other drug containing as NSAID (prescription or non-prescription) ■ taking a blood thinning (anti-coagulated) or steroid drug ■ 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 ■ 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 ■ 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
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Directions
Adults and children 12 years and older do not take more than directed - the smallest effective dose should be used - take 1 tablet every 4 to 6 hours while symptoms persist - If pain or fever does not respond to 1 tablet take a 2nd tablet - do not exceed 6 tablets in 24 hours unless directed by a doctor
Children under 12 years of age do not use unless directed by a doctor
- Other Information:
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REDICARE IBUPROFEN
ibuprofen 200mg tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71105-750 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 in 200 Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code IBU;200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71105-750-68 1 in 1 BOX; Type 0: Not a Combination Product 02/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079129 02/01/2017 Labeler - Redicare LLC (800149346)