Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen 500 mg tablet

  • NDC Code(s): 69168-328-01, 69168-328-03, 69168-328-13, 69168-328-40
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 13, 2020

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  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporary relief of minor aches and pains associated with   ■ the common cold   ■ headache    ■  toothache   ■ muscular aches   ■ backache     ■ minor pain from arthritis  

    ■ premenstrual  and menstrual cramps   ■ temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take n more than 4,000mg
    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 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 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 breastfeeding

    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 (1-800-222-1222) right away.
    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 use 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 more than 10 days unless directed by a doctor  

    Children under 12 years: Consult a doctor

  • Other information

    ■ store between 20º-25ºC (68º-77ºF)
    ■ do not use if imprinted safety seal under cap is broken or missing

  • Inactive Ingredients

    corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • Questions or Comments

    Call 1-888-952-0050 Monday to Friday 9am-5pm EST

  • Package/Label Principal Display Panel

    Health A2Z®

    Compare to Tylenol® active ingredient*

    See New Warnings Information

    Extra Strength
    PAIN RELIEF
    Acetaminophen
    Pain Reliever-Fever Reducer
    CONTAINS NO ASPIRIN

    500 mg
    Pain Relief

    Pain Relief

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen 500 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-328
    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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ328
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-328-4040 in 1 CARTON; Type 0: Not a Combination Product12/17/2014
    2NDC:69168-328-01100 in 1 CARTON; Type 0: Not a Combination Product12/17/2014
    3NDC:69168-328-13175 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2014
    4NDC:69168-328-03250 in 1 BOTTLE; Type 0: Not a Combination Product12/17/201405/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/17/2014
    Labeler - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930analysis(69168-328) , label(69168-328) , manufacture(69168-328) , pack(69168-328)
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