Label: IBUPROFEN tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 65692-0412-1 - Packager: Raining Rose Inc.
- 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 5, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug FactsActive ingredient
- Purpose
- Keep out of reach of children
- 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 • skin reddening • facial swelling • rash • asthma (wheezing) • blister • shock If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinner (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (asprin, 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 a doctor before use if
• stomach bleeding warning applies to you • you have a history of stomach problems such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have problems or serious side effects from taking pain relivers or fever reducers • you have asthma
- Ask a doctor or pharmacist before use if you are
- When using this product
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Stop use and ask a doctor if
• you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or blackstools • have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new or unexpected symptoms appear.
- If pregnant or breast-feeding,
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Directions
• do not use more than directed • the smallest effective dose should be used • Adults and children (12 years 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: Do not give to children under 12 years of age.
- Inactive ingredients:
- Other Information
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Ibuprofen product label
IBUPROFEN
12 Ibuprofen Tablets USP, 200 mPain Reliever/Fever Reducer (NSAID)
LOT CODE:
EXP DATE:
OPEN HERE TO VIE COMPLETE PRODUCT INFORMATION
Do not use if safety seal is broken.
TAMPER EVIDENT: DO NOT USE IF THIS SAFETY SEAL AROUND CAP IS BROKEN OR MISSING
TEAR HERE TO OPEN
Dist. By Raining Rose, Inc. Cedar Rapids, IA 52403
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0412 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 CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOl (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;532 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-0412-1 12 in 1 VIAL; Type 0: Not a Combination Product 08/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/01/2015 Labeler - Raining Rose Inc. (083819404) Registrant - Raining Rose Inc. (083819404) Establishment Name Address ID/FEI Business Operations Raining Rose Inc. 083819404 manufacture(65692-0412) , relabel(65692-0412) , repack(65692-0412)