Label: ACETAMINOPHEN- acetaminophen caplet, 500 mg extra strength tablet

  • 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 July 28, 2020

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  • SPL UNCLASSIFIED SECTION

    Important: Read all product information before using. Keep this box for important information.

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen USP 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to

    • headache
    • tooth pain
    • backache
    • PMS and menstrual cramps
    • temporarily reduces fever
    • minor arthritis
    • the common cold
    • muscular pain 
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets 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

    Allergy alert: Acetaminophen may cause severe skin reaction. 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.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor

    Stop use and ask a doctor if

    • You are suffering from any liver disease
    • you are taking the blood thinning drug warfarin
    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

  • Dosage

    Adults and children over 12 years of age, Take 2 caplets every 6 hours while symptoms last, do not take more than 6 caplets in 24 hours, unless directed by a doctor. 

    Children under 12    , ask a doctor. 

  • Storage

    • Store in a cool and dry place
    • Store between 22-25˚C (67-77˚F)
  • Inactive ingredients

    Micro crystalline Cellulose, Corn Starch, Sodium Starch Glycolate Type A, Sodium Lauryl sulfate, Sodium Methyl Paraben, Magnesium Stearate, Talc, Croscarmellose Sodium and polyvinyl pyrrolidone K-30

  • Information

    Tamper Evident: Do not use if safety seal under cap is broken or missing

    Swallow whole, do not crush, chew, split or dissolve

  • PRINCIPAL DISPLAY PANEL - 200 CT 

    Acetaminophen Caplet, 500 mg

    Pain Reliever - Fever Reducer

    image description

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen caplet, 500 mg extra strength tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77800-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    Colorwhite (White to Off-White) Score2 pieces
    ShapeCAPSULE (Caplet Shape) Size18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77800-100-01200 in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/24/2020
    Labeler - HealthRight Products, LLC (831577916)
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