Label: ACETAMINOPHEN 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 December 30, 2019

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  • Active ingredients (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 case 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 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

    • pain gets worse or last 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

    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 the product at controlled room temperature 15°-30°C (59°-86°F).
    • Protect from light, moisture and freezing.
  • Inactive ingredients

    hypromellose, polyethylene glycol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid.

  • Questions or comments?

    Call toll free: 1-800-456-7077

  • Principal Display Panel – Pouch Label

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    Safetec
    of America, Inc.

    Manufactured for Safetec of America, Inc.
    Buffalo NY 14215

    Acetaminophen 500 mg

    Pain Reliever/Fever Reducer

    Principal Display Panel – Pouch Label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4406
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
    Inactive Ingredients
    Ingredient NameStrength
    hypromellose 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    povidone k30 (UNII: U725QWY32X)  
    starch, corn (UNII: O8232NY3SJ)  
    sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
    stearic acid (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeOVAL (OVAL) Size17mm
    FlavorImprint Code 500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4406-02 in 1 POUCH; Type 0: Not a Combination Product12/30/2019
    2NDC:61010-4406-150 in 1 BOX12/30/2019
    2NDC:61010-4406-02 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:61010-4406-2100 in 1 BOX12/30/2019
    3NDC:61010-4406-02 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/30/2019
    Labeler - Safetec of America, Inc. (874965262)
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