Label: EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet, coated

  • NDC Code(s): 68016-029-14, 68016-029-20, 68016-029-47
  • Packager: Chain Drug Consortium, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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  • Active ingredient

    Acetaminophen 500 mg

  • Purpose


    Pain Reliever/Fever Reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
    • - headache
    • - muscular aches
    • - backache
    • - arthritis
    • - the common cold
    • - toothache
    • - menstrual cramps

    • temporarily reduces fever
  • Warnings

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 gelcaps 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.

    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 symptom 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.

    Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Keep out of reach of children.

  • Directions

    • Do not take more than directed (see overdose warnings)
      Adults and children 12 years and over
      • Take 2 gelcaps every 4-6 hours, as needed.
      • Do not take more than 8 gelcaps in 24 hours
      Children under 12 yearsDo not use
  • Other Information

    • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
    • store at controlled room temperature 20⁰C-25⁰C (68⁰F-77⁰F)
    • avoid high humidity

    Inactive Ingredients

    croscarmellose sodium, D&C Red #33, FD&C Blue #1, FD&C Red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide, PEG, povidone, propylene glycol, shellac glaze, starch, stearic acid, titanium dioxide.

  • package label

    NDC 68016-029-47

    Compare to active ingredient in Extra Strength Tylenol Rapid Release Gels*

    Extra Strength

    PAIN RELIEF

    ACETAMINOPHEN

    Rapid Release

    Pain Reliever/ Fever Reducer

    Gelcaps

    400 Gelcaps

    500 mg each

    251 label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    Colorred (with blue and a gray band) Scoreno score
    ShapeCAPSULE (Gelcap) Size19mm
    FlavorImprint Code L;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-029-201 in 1 CARTON09/01/2007
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68016-029-141 in 1 CARTON09/01/200708/31/2022
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68016-029-47400 in 1 BOTTLE; Type 0: Not a Combination Product09/01/200704/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/01/2007
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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