Label: 8 HR PAIN RELIEF- acetaminophen tablet, extended release
- NDC Code(s): 55910-895-05
- Packager: DOLGENCORP, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 20, 2023
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- Drug Facts
- 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 6 caplets 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.
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product
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DOSAGE & ADMINISTRATION
Directions
Do not take more than directed.
See overdose warning
adults and children 12 years and over• take 2 caplets every 8 hours with water
• swallow whole; do not crush, chew, split, or dissolve
• do not take more than 6 caplets in 24 hours
• do not use for more than 10 days unless directed by a doctor
children under 12 years• do not use
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
8 HR PAIN RELIEF
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-895 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) TRIACETIN (UNII: XHX3C3X673) CARNAUBA WAX (UNII: R12CBM0EIZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (White to off White) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 71 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-895-05 1 in 1 BOTTLE 04/29/2023 1 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215486 04/29/2023 Labeler - DOLGENCORP, INC. (068331990) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations Marksans Pharma Ltd 925822975 manufacture(55910-895)