Label: NON-ASPIRIN- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67060-210-67, 67060-210-68 - Packager: ADVANCED FIRST AID, 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 April 10, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings:
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: • you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product
Do not use: • with any other product containing acetaminophen • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor
When using this product do not exceed recommended dose.
Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or asdirected by a doctor.
Children under 12 years: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NON-ASPIRIN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-210 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code FR1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67060-210-68 100 in 1 CARTON 04/10/2015 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:67060-210-67 250 in 1 CARTON 04/10/2015 2 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 OTC monograph not final part343 04/10/2015 Labeler - ADVANCED FIRST AID, INC. (114477180) Registrant - ADVANCED FIRST AID, INC. (114477180) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(67060-210) Establishment Name Address ID/FEI Business Operations ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-210)
