Label: PAIN RELIEVER- acetaminophen 500mg, film-coated caplet tablet, film coated
EXTRA STRENGTH PAIN RELIEVER, CASEYS 4GOOD- acetaminophen 500mg, film-coated caplet tablet, film coated

  • NDC Code(s): 66715-6321-4, 66715-6871-4
  • Packager: Lil' Drug Store Products, Inc.
  • 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 August 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 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 years
  • 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 JOHNSON & JOHNSON CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.

  • Extra Strength Pain Reliever, Lil' Drug Store, 50ct PDP/Package

    [caduceus]

    Compare to the Active
    Ingredient in Tylenol®
    Extra Strength Caplets**

    Extra Strength
    Pain Reliever

    Acetaminophen 500 mg
    Pain Reliever/Fever Reducer

    [caplet image]

    ACTUAL SIZE

    50Caplets

    [Lil' Drug Store logo]

    PDP/Package

  • Extra Strength Pain Reliever, Casey's 4good, 50ct PDP/Package

    EXTRA STRENGTH

    Pain Reliever

    Acetaminophen 500 mg

    Pain Reliever/Fever Reducer

    Compare to the

    active ingredient

    in Tylenol® Extra

    Strength*

    [caplet image]

    actual

    size

    [ Casey's 4good logo TM]

    50 CAPLETS

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER 
    acetaminophen 500mg, film-coated caplet tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6871
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)  
    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:66715-6871-41 in 1 CARTON03/04/2022
    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 finalM01303/04/2022
    EXTRA STRENGTH PAIN RELIEVER, CASEYS 4GOOD 
    acetaminophen 500mg, film-coated caplet tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6321
    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:66715-6321-41 in 1 CARTON08/01/2023
    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 finalM01308/01/2023
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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