Label: FIRST AID ONLY IBUPROFEN- ibuprofen tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 0924-0275-01 - Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 47682-600
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 4, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Drug Facts
- Purpose
- Uses
- Warnings
- Allergy Alert:
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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 thinning (anticoagulant) or steroid drug
■ take other drugs containing prescription or nonprescription NSAIDs (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
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Ask a doctor before use if
■ you have problems or serious side effects from taking pain relievers or fever reducers
■ 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 have asthma
■ you are taking a diuretic
- 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 black stools
■ have stomach pain that does not get better
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ redness or swelling is present in the painful area
■ any new or unexpected symptoms occur
- If pregnant or breast feeding,
- Keep out of reach of Children.
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Directions
■ do not use 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 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.
- Other information
- Inactive ingredients
- Questions or comments?
- First Aid Only Ibuprofen Label
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INGREDIENTS AND APPEARANCE
FIRST AID ONLY IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0275(NDC:47682-600) 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) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-0275-01 20 in 1 BOX, UNIT-DOSE 01/26/2017 1 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 ANDA ANDA075010 02/01/2016 Labeler - Acme United Corporation (001180207) Registrant - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-0275) , repack(0924-0275) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-0275) , repack(0924-0275)