Label: ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet

  • NDC Code(s): 69842-093-01, 69842-093-10, 69842-093-15, 69842-093-24
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 21, 2022

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  • Active ingredient (in each caplet)

    Acetaminophen 650 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • muscular aches
      • minor pain of arthritis
      • backache
      • toothache
      • premenstrual and menstrual cramps
      • headache
      • the common cold
    • 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 ever 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 a 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 (1800-222-1222) right away. 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 of age: ask a doctor
  • Other information

    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hydroxyethyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose povidone, pregelatinized starch, sodium lauryl sulfate


  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    †Compare to the active ingredient of Tylenol® 8HR Muscle Aches & Pain

    Extended-release

    Pain Reliever

    Acetaminophen 650 mg

    Pain reliever/Fever reducer

    For up to 8 hours relief of minor muscle aches & pain

    Caplets*

    (*capsule-shaped bi-layer tablets)

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Muscle Aches & Pain.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by: CVS Pharmacy Inc

    one CVS Drive, Woonsocket RI 02895

  • Product Label

    Acetaminophen 650 mg

    CVS HEALTH 8HR Arthritis Pain Relief

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  EXTENDED RELEASE
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-093
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 511
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-093-101 in 1 BOX04/01/202004/30/2025
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69842-093-241 in 1 BOX04/01/202004/30/2025
    224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:69842-093-151 in 1 BOX04/01/202004/30/2025
    3150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:69842-093-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/202004/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20703504/01/202004/30/2025
    Labeler - CVS Pharmacy (062312574)
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