Label: NON-ASPIRIN ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 71105-210-68 - Packager: Redicare LLC
- Category: HUMAN OTC DRUG LABEL
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 July 2, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet) ..................................................... Purpose
- Uses:
- Warnings:
- Do not use:
- When using this product do not exceed recommended dose.
- Stop use and ask a doctor if
- If pregnant or breast-feeding a baby,
- KEEP OUT OF REACH OF CHILDREN.
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Directions:
Adults and children 12 years of age or older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor
Children under 12 years of age: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. - Other Information:
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NON-ASPIRIN ACETAMINOPHEN
non-aspirin acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71105-210 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 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:71105-210-68 100 in 1 CARTON; Type 0: Not a Combination Product 10/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/01/2017 Labeler - Redicare LLC (800149346)