FEM RELIEF (ACETAMINOPHEN PAMABROM) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]

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FEM RELIEF (ACETAMINOPHEN PAMABROM) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-7000-01, 0498-7000-10, 0498-7000-25, 0498-7000-50, 0498-7001-01, 0498-7001-25
Set ID 1be326af-0a12-4a69-be5d-32bbffc6dbad
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

    Pamabrom 25 mg

  • Purpose

    Pain reliever/fever reducer

    Diuretic

  • Uses

    temporarily relieves

    • premenstrual and menstrual cramps
    • minor aches and pains and temporary weight gain, bloating, swelling, and full feeling associated with the premenstrual and menstrual periods
  • Warnings

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

    • more than 8 tablets 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 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.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor

    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

    • new symptoms occur
    • redness or swelling is present

    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 the 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 and over: take 2 tablets with water every 4 hours while symptoms persist, not to exceed 8 tablets in 24 hours.
    • Children under 12: consult a doctor
  • Other information

    • store at room temperature
    • salt free
    • sugar free
    • antihistamine free
    • caffeine free
    • TAMPER EVIDENT PACKETS-DO NOT USE IF OPEN OR TORN
  • Inactive ingredients

    corn starch, D&C yellow #10, FD&C Blue #1, microcrystalline cellulose, povidone, stearic acid

  • Questions or comments?

    1-800-430-5490

  • PRINCIPAL DISPLAY PANEL

    MM1 Fem Relief 100 Packet Box

  • Fem Relief label

    Honeywell FemRelief

  • INGREDIENTS AND APPEARANCE
    FEM RELIEF 
    acetaminophen pamabrom tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-7001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (WHITE W RED AND GREEN SPOTS) Scoreno score
    ShapeROUND (FR7) Size11mm
    FlavorImprint Code FR7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-7001-25250 in 1 BOX01/02/2017
    1NDC:0498-7001-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/2017
    FEM RELIEF 
    acetaminophen pamabrom tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-7000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    Colorwhite (WHITE W RED AND GREEN SPOTS) Scoreno score
    ShapeROUND (FR7) Size11mm
    FlavorImprint Code FR7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-7000-50250 in 1 BOX02/15/201201/01/2017
    1NDC:0498-7000-25125 in 1 BOX
    1NDC:0498-7000-1050 in 1 BOX
    1NDC:0498-7000-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/15/201201/01/2017
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321repack(0498-7000, 0498-7001)
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