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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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)
    Acetaminophen 650 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses
    • temporarily relieves minor aches and pains due to:
    o minor pain of arthritis
    o muscular aches
    o backache
    o premenstrual and menstrual cramps
    o the common cold
    o headache
    o toothache
    • temporarily reduces fever

  • 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

    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

  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

  • STOP USE

    Stop use and ask a doctor if
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present
    These could be signs of a serious condition

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    Overdose warning:     In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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

    Other information
    • store between 20-25ºC (68-77ºF)
    • The FDA approved Dissolution methods differ from USP

  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, povidone, pregelatinized starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, triacetin

  • QUESTIONS

    Questions or comments?
    Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    apap-650mg-100s-labelapap-650mg-24s-labelapap-650mg-24s-carton

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEVER 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9781
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorwhite (White to off-white) Scoreno score
    ShapeCAPSULE (Capsule-shaped tablet) Size19mm
    FlavorImprint Code 71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9781-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2022
    2NDC:0363-9781-421 in 1 CARTON11/22/2022
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21548609/28/2022
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(0363-9781)
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