Label: ARTHRITIS PAIN RELIEVER- acetaminophen tablet, extended release
- NDC Code(s): 0363-9781-01, 0363-9781-42
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 15, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- Do not take more than directed
- See overdose warning
adults
- 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
under 18 years of age - ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ARTHRITIS PAIN RELIEVER
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9781 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) POVIDONE K30 (UNII: U725QWY32X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white (White to off-white) Score no score Shape CAPSULE (Capsule-shaped tablet) Size 19mm Flavor Imprint Code 71 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9781-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2022 2 NDC:0363-9781-42 1 in 1 CARTON 11/22/2022 2 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 ANDA ANDA215486 09/28/2022 Labeler - WALGREENS (008965063) Registrant - TIME CAP LABORATORIES INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(0363-9781)