Label: NON-ASPIRIN- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52124-0010-1 - Packager: Genuine First Aid LLC
- 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 December 30, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product
- Do not use
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Inactive Ingredients
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DOSAGE & ADMINISTRATION
Directions
Adults and Children Take 2 tablets every 4 to 6 hours as
12 years of age needed. Do not take more than 12 tablets
or older in 24 hours.
Children 6-11 years Take 1 tablet every 4 to 6 hours as
of age needed. Do not take more than 5
tablets in 24 hours.
Children under 6 Do not use this regular strength product.
years of age This will provide more than the
recommended dose (overdose) and could
cause serious health problems.
- STORAGE AND HANDLING
- GENERAL PRECAUTIONS
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NON-ASPIRIN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color white (WHITE) Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ;234 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0010-1 2 in 1 PACKAGE; Type 0: Not a Combination Product 04/23/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/23/2010 Labeler - Genuine First Aid LLC (619609857) Establishment Name Address ID/FEI Business Operations Future Pak Ltd. 087737672 manufacture(52124-0010)