Label: ACETAMINOPHEN 8 HOUR- acetaminophen tablet, film coated, extended release

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

Drug Label Information

Updated March 7, 2013

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  • ACTIVE INGREDIENT (IN EACH CAPLET)

    Acetaminophen USP, 650 mg

  • PURPOSE

    Pain reliever/fever reducer

  • USES

    • temporarily relieves minor aches and pains due to:
      • muscular aches
      • backache
      • headache
      • minor pain of arthritis
    • temporarily reduces fever
  • 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

    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.

  • 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
  • OTHER INFORMATION

    • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
    • see end panel for batch number and expiration date
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • INACTIVE INGREDIENTS

    Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    CVS pharmacy®

    Compare to the active ingredient in Tylenol®8 Hour†

    Use only as directed.

    See New Warnings Information

    Lasts up to 8 Hour

    GLUTEN FREE

    DYE FREE

    PAIN RELIEF

    CAPLETS*

    ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg

    • Pain Reliever/Fever Reducer
    • For up to 8 Hour Relief of Minor Muscular Aches & Pain

    100 CAPLETS*

    650 mg EACH

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    (*Capsule-Shaped Tablets)

    Distributed by: CVS Pharmacy, Inc.

    5095677/R0512

    100's bottle carton label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 8 HOUR 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-336
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Capsule Shaped) Size19mm
    FlavorImprint Code cor116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-336-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07620004/30/2002
    Labeler - CVS Pharmacy (062312574)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(59779-336)
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