PAIN RELIEFEXTRA STRENGTH EXTRA STRENGTH (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]

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PAIN RELIEFEXTRA STRENGTH EXTRA STRENGTH (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]
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NDC 69168-235-05
Set ID d72d83b8-54ff-4bc4-b66e-bb10d9913f74
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporary relief of minor aches and pains associated with    ■ common cold    ■  headache    ■ toothache    ■ muscular aches   ■ backache    ■ arthritis     ■  menstrual cramps   ■  and reduction of fever

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 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

    ■ if you are allergic to acetaminophen   ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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

    symptoms do not improve pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present ■ a rare
    sensitivity reaction occurs You may report side effects to 1-888-952-0050

    If pregnant or breast-feeding

    ask a health professional before use

    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

    ■ symptoms do not improve   ■ pain gets worse or lasts for more than 10 days   ■ fever gets worse or lasts for more than 3 days   ■ new symptoms occur   ■ redness or swelling is present   ■ a rare sensitivity reaction occurs

  • If you are pregnant or breast-feeding,

    ask a health professional before use.

  • Keep Out of Reach of Children.

    In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
    Do not exceed recommended dosage.

  • Directions

    ■ do not use more than directed (see overdose warning)
    ■ adults and children 12 years and over:     take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.
    ■  do not use more than 10 days unless directed by a doctor
    ■ children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Inactive Ingredients

    corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.
    May contain povidone, and sodium starch glycolate.

  • Package/Label Principal Display Panel

    Health A2Z®                    Compare to Tylenol® active ingredient*

    See New Warnings Information

    Extra Strength
    PAIN RELIEF
    500mg
    Acetaminophen

    Pain Reliever-Fever Reducer
    CONTAINS NO ASPIRIN

    50 Tablets

    Health A2Z 235

    Health A2Z 235

     

    Label 235

    Label 235

          
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEFEXTRA STRENGTH  EXTRA STRENGTH
    acetaminophen 500 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-235
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-235-0550 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/17/2014
    Labeler - Allegiant Health (079501930)
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