Label: ACETAMINOPHEN tablet

  • NDC Code(s): 30142-561-62, 30142-561-71, 30142-561-76, 30142-561-78, view more
    30142-561-82, 30142-561-85, 30142-561-90
  • Packager: Kroger Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 3, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • 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: 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

    •
    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 have ever had an allergic reaction to this product or any of its ingredients

    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 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

    •
    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

    ask a doctor
  • Other information

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

    carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

    *may contain one or more of these ingredients

  • Questions or comments?

    1-800-632-6900

  • Principal Display Panel

    COMPARE TO the active ingredient of EXTRA STRENGTH TYLENOL® CAPLETS

    See back panel

    OUR PHARMACIST RECOMMENDED

    for adults

    Extra Strength

    actual size

    Acetaminophen 500 mg

    Pain Reliever/Fever Reducer

    100 CAPLETS 500 mg EACH

    acetaminophen image 1
    acetaminophen image 2
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-561
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVAL (caplet) Size16mm
    FlavorImprint Code L484
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-561-711 in 1 CARTON07/15/198704/30/2020
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:30142-561-781 in 1 CARTON07/15/1987
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:30142-561-851 in 1 CARTON07/15/198707/15/1987
    3250 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:30142-561-90500 in 1 BOTTLE; Type 0: Not a Combination Product07/15/198703/01/2023
    5NDC:30142-561-822 in 1 CARTON07/15/198707/15/1987
    5100 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:30142-561-761 in 1 CARTON07/15/198711/30/2020
    6120 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:30142-561-621 in 1 CARTON05/10/201811/30/2022
    724 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/15/1987
    Labeler - Kroger Company (006999528)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!