NDC | 69168-353-99 |
Set ID | 3329f052-a069-4a36-a3be-882f55a0f831 |
Category | HUMAN OTC DRUG LABEL |
Packager | Allegiant Health |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
- If pregnant or breast-feeding
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Keep Out of Reach of Children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
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Directions
- do not use more than directed (see overdose warning)
- adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.
- Do not use more than 10 days unless directed by a doctor
- children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
PAIN RELIEF EASY TO SWALLOW EXTRA STRENGTH EASY TO SWALLOW
acetaminophen 500 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-353 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 CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND Size 12mm Flavor Imprint Code TCL342 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-353-99 1 in 1 CARTON 12/17/2014 1 24 in 1 BOTTLE; 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 12/17/2014 Labeler - Allegiant Health (079501930) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 LABEL(69168-353) , PACK(69168-353)