Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen 500 mg, film-coated caplet tablet, film coated

  • NDC Code(s): 66715-5680-4
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 14, 2023

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  • Drug Facts

  • Active ingredient

    Active ingredient(in each caplet)

    Acetaminophen USP 500 mg

  • Purpose

    Purpose

    Pain reliever/fever reducer

  • Uses

    Uses

    • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever
  • Warnings

    Liver warning

    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

    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 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

    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

    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

    Directions

    • do not take more than directed (see Overdose warning)
    adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children under 12 yearsask a doctor

  • Other information

    Other information

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

    Inactive ingredients povidone, pregelatinized starch (maize), stearic acid

  • Questions

    Questions or comments?
    Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • SPL UNCLASSIFIED SECTION

    **This product is not manufactured or distributed by McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.

  • PDP/Package

    TEMPORARILY RELIEVES
    MINOR ACHES & PAINS
    Compare to the active ingredient in
    Tylenol® Extra Strength Caplets**

    [Circle K logo]

    extra strength
    pain reliever
    50 caplets
    Acetaminophen 500 mg
    Pain Reliever/Fever Reducer

    [caplet image]

    actual size

    50 caplets

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen 500 mg, film-coated caplet tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5680
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeOVAL (capsule-shaped biconvex) Size18mm
    FlavorImprint Code N79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-5680-41 in 1 CARTON05/09/2022
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/09/2022
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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