Label: HELP I HAVE AN ACHING BODY- ibuprofen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 49260-615-16, 49260-615-50 - Packager: Help Remedies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 5, 2013
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- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings
Allergy Alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin Symptoms may include:
• shock • hives • facial swelling • asthma (wheezing) • rash • skin reddening • 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.
Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are the 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
more than 10 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear.
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 • bleeding problems • ulcers • high blood
pressure • taken a diuretic • heart or kidney disease • reached age 60 or older.
Ask a doctor or pharmacist before use if you are • taking any other drug containing an NSAID (prescription or non prescription)
• taking a blood thinning agent (anticoagulant) or steroid drug • taking any other drug • under a doctor’s care for any serious condition.
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
When using this product
• take with food or milk if stomach upset occurs • long term continuous use may increase the risk of a heart attack or stroke.
Adults and children 12 years and over: 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 yeas: ask a doctor • do not take more than directed
• the smallest effective dose should be used
- INDICATIONS & USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
HELP I HAVE AN ACHING BODY
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49260-615 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (white) Score no score Shape ROUND (round) Size 10mm Flavor Imprint Code 44352 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49260-615-50 50 in 1 BOTTLE 2 NDC:49260-615-16 16 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075139 07/01/2009 Labeler - Help Remedies, Inc. (050359682)