Label: APROFEN REGULAR STRENGTH- ibuprofen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 46084-021-22, 46084-021-23, 46084-021-24, 46084-021-26, view more46084-021-31 - Packager: A P J Laboratories Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 21, 2013
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
rash
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 severe stomach bleeding. The chances are 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
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DOSAGE & ADMINISTRATION
do not take 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: ask a doctor - INACTIVE INGREDIENT
- INACTIVE INGREDIENT
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- INACTIVE INGREDIENT
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
APROFEN REGULAR STRENGTH
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-021 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 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 40 mg STARCH, CORN (UNII: O8232NY3SJ) 20 mg GELATIN (UNII: 2G86QN327L) 2 mg METHYLPARABEN (UNII: A2I8C7HI9T) 3 mg TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.1 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 10 mg TALC (UNII: 7SEV7J4R1U) 10 mg SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 20 mg SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1 mg Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 200mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-021-26 500 in 1 BLISTER PACK 2 NDC:46084-021-24 250 in 1 BLISTER PACK 3 NDC:46084-021-23 100 in 1 BLISTER PACK 4 NDC:46084-021-22 50 in 1 BLISTER PACK 5 NDC:46084-021-31 2 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 02/21/2013 Labeler - A P J Laboratories Limited (677378339) Registrant - A P J Laboratories Limited (677378339) Establishment Name Address ID/FEI Business Operations A P J Laboratories Limited 677378339 manufacture(46084-021)
