AYPANAL EX (ACETAMINOPHEN) TABLET SWIFT AYPANAL EXTRA (ACETAMINOPHEN) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]

  • Home
  • AYPANAL EX (ACETAMINOPHEN) TABLET SWIFT AYPANAL EXTRA (ACETAMINOPHEN) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]

AYPANAL EX (ACETAMINOPHEN) TABLET SWIFT AYPANAL EXTRA (ACETAMINOPHEN) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]
PDF | XML
NDC 0498-2100-01, 0498-2100-10, 0498-2100-25, 0498-2100-50, 0498-2110-01, 0498-2110-10, 0498-2110-25, 0498-2110-50
Set ID 0a0d9512-b904-408f-9084-45a04f744803
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, Inc
Generic Name
Product Class
Product Number
Application Number PART343
View All Sections
  • Active ingredients (in each tablet)

    Acetaminophen 500 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.
    • 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 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.

    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

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: In case ofl overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 and over: Take 2 tablets with water every 6 hours while symptoms last.
    • do not take any more than 8 tablets in 24 hours.
    • children under 12: consult a doctor
  • Other Information

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

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

  • Questions or comments?

    1-800-430-5490

  • Aypanal Extra 100CT

    MM1 Aypanal Extra 100 count box

  • Aypanal EX

    EXAypanal

  • INGREDIENTS AND APPEARANCE
    AYPANAL EX 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2110
    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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2110-10100 in 1 BOX01/02/2017
    1NDC:0498-2110-012 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-2110-25250 in 1 BOX01/02/2017
    2NDC:0498-2110-012 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0498-2110-50500 in 1 BOX01/02/2017
    3NDC:0498-2110-012 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
    SWIFT AYPANAL EXTRA 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2100(NDC:62959-210)
    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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (SNOW WHITE) Scoreno score
    ShapeROUND (FR1) Size12mm
    FlavorImprint Code FR1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-2100-50500 in 1 BOX04/14/201101/01/2017
    1NDC:0498-2100-25250 in 1 BOX
    1NDC:0498-2100-10100 in 1 BOX
    1NDC:0498-2100-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/14/201112/01/2017
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321repack(0498-2100, 0498-2110)
View All Sections

Related Drugs

Search DailyMed Drugs