Label: 8 HOUR PAIN RELIEF- acetaminophen tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 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:

    • muscular aches
    • backache
    • minor pain of arthritis
    • toothache
    • premenstrual and menstrual cramps
    • headache
    • the common cold

    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

    • 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 a doctor before use if you have liver disease

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

    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.

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

    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 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

    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, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

  • QUESTIONS

    Questions or comments? Call 1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    apap-mp-100-labelapap-mp-100-ifc

  • INGREDIENTS AND APPEARANCE
    8 HOUR PAIN RELIEF 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-704
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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:41226-704-011 in 1 CARTON04/15/2024
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21548604/15/2024
    Labeler - KROGER COMPANY (006999528)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(41226-704)
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