AYPANAL (ACETAMINOPHEN) TABLET AYPANAL NON-ASPIRIN (ACETAMINOPHEN) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]

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AYPANAL (ACETAMINOPHEN) TABLET AYPANAL NON-ASPIRIN (ACETAMINOPHEN) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-2000-05, 0498-2000-06, 0498-2000-10, 0498-2000-25, 0498-2000-50, 0498-2001-01, 0498-2001-03, 0498-2001-10, 0498-2001-25, 0498-2001-50
Set ID b25afe51-19d1-463d-8ff0-c159ed9076eb
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, Inc
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to the common cold and headache
    • temporarily reduces fever
  • Warnings

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

    • more than 4,000 mg in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 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 rash 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.

    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 using and ask a doctor if

    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    If pregnant or breast-feeding

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

    Keep out of reach of children

    Keep out of reach of children.

    Overdose warning: 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.

  • Directions

    • do not take more than directed (see overdose warning)
    • adults and children 12 years of age or older
    • take two tablets every 4-6 hours while symptoms last
    • do not take more than 12 tablets in 24 hours
    • children 6 to under 12 years of age
    • take 1 tablet every 4-6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • children under 6 years
    • consult a doctor
  • Other information

    • store at room temperature 15 o to 30 oC (59 o - 86 oF)
    • TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN
  • Inactive ingredients

    corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-800-430-5490

  • North Aypanal

    image of pdp

  • Honeywell Aypanal

    Aypnal

  • INGREDIENTS AND APPEARANCE
    AYPANAL 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (White) Score2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code Circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2000-0626 in 1 BOX, UNIT-DOSE04/10/201201/01/2017
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-2000-0550 in 1 BOX, UNIT-DOSE04/10/201201/01/2017
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0498-2000-10100 in 1 BOX, UNIT-DOSE04/10/201201/01/2017
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0498-2000-25250 in 1 BOX, UNIT-DOSE04/10/201201/01/2017
    42 in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0498-2000-50500 in 1 BOX, UNIT-DOSE04/10/201201/01/2017
    52 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/201201/01/2017
    AYPANAL NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code circle;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2001-10100 in 1 BOX01/02/2017
    1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-2001-0325 in 1 BOX01/02/2017
    2NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0498-2001-25250 in 1 BOX01/02/2017
    3NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0498-2001-50500 in 1 BOX01/02/2017
    4NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/02/2017
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321repack(0498-2001, 0498-2000)
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