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

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PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]
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NDC 69168-328-01, 69168-328-03, 69168-328-13, 69168-328-40
Set ID 8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART343
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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   ■ 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, 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 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

  • 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 caplets every 6 hours. Do not take more than 8 caplets in 24 hours.   ■ Do not use more than 10 days unless directed by a doctor   ■ children u nder 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 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.

  • Other information

    ■ store at room temperature   ■ do not use if imprinted safety seal under cap is broken or missing

  • Inactive Ingredients

    corn starch, pregelatinized starch, stearic acid. May contain povidone and sodium starch glycolates.

  • 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
    40 Caplets

     H2Z 328

    H2Z 328

     
    328 Label

    328 Label

  • 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)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ328
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-328-01100 in 1 CARTON; Type 0: Not a Combination Product12/17/2014
    2NDC:69168-328-03250 in 1 BOTTLE; Type 0: Not a Combination Product12/17/201405/31/2018
    3NDC:69168-328-13175 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2014
    4NDC:69168-328-4040 in 1 CARTON; Type 0: Not a Combination Product12/17/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/17/2014
    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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