Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablets 500 mg tablet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 14, 2021

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient
    (in each tablet)
    Acetaminophen 500 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses
    temporarily relieves minor aches and pains due to:

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

    temporarily reduces fever

  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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 poduct
  • 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 using 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions
    do not take more than directed (see overdose warning)
    adults and children 12 years and over:

    • take 2 tablets every 6 hours while symptoms last
    • do not take more than 6 tablets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor

    children under 12 years: ask a doctor

  • OTHER INFORMATION

    Other information

    • store between 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, FD&C Red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized
    starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide *may contain this ingredient

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    342R-Walgreens-Pain-Reliever-bottle-label-50s342R-Walgreens-Pain-Reliever-carton-label-50s

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen tablets 500 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0684
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code TCL342
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0684-051 in 1 CARTON10/13/2021
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/13/2021
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(0363-0684)
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