Label: APINOPHEN EXTRA STRENGTH- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 46084-061-11, 46084-061-22, 46084-061-23, 46084-061-24, view more46084-061-25, 46084-061-26 - Packager: A P J Laboratories Limited
- 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 January 2, 2014
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- Official Label (Printer Friendly)
- active ingredient
- purpose
- keep out of reach of children
- uses
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warning
Liver warning:
This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
more than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
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directions
do not take more than directed (see overdose warning)
adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last
swallow whole – do not crush, chew, or dissolve
do not take more than 6 caplets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor
children under 12 years : ask a doctor
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INGREDIENTS AND APPEARANCE
APINOPHEN EXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-061 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 10 mg STARCH, CORN (UNII: O8232NY3SJ) 17 mg GELATIN (UNII: 2G86QN327L) 2 mg METHYLPARABEN (UNII: A2I8C7HI9T) 10 mg PROPYLPARABEN (UNII: Z8IX2SC1OH) 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 2 pieces Shape ROUND Size 13mm Flavor Imprint Code 500mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-061-25 500 in 1 BLISTER PACK 2 NDC:46084-061-24 250 in 1 BLISTER PACK 3 NDC:46084-061-23 120 in 1 BLISTER PACK 4 NDC:46084-061-22 60 in 1 BLISTER PACK 5 NDC:46084-061-11 2 in 1 BLISTER PACK 6 NDC:46084-061-26 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/01/2013 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(46084-061)
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