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Fem Relief (North Safety Products LLC)

Available Formats

Dosage Form Package Information Links
TABLET 250 BOX in 1 BOX (0498-7000-50) > 125 BOX in 1 BOX (0498-7000-25) > 50 PACKET in 1 BOX (0498-7000-10) > 2 TABLET in 1 PACKET (0498-7000-01) Label Information

Complete Fem Relief Information

  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

    Pamabrom 25 mg


  • Purpose

    Pain reliever/diuretic


  • Uses

    for the relief of

    • pain of the premenstrual and menstrual periods
    • pain of dysmenorrhea
    • temporary weight gain, bloating, swelling and/or 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
    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
    • 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
    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse

  • 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. 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

    • 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

    • salt free
    • sugar free
    • antihistamine free
    • caffeine free
    • store at room temperature
    • tamper evident, do not use if packet is torn or open

  • 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

    FemRelief


  • INGREDIENTS AND APPEARANCE
    FEM RELIEF 
    acetaminophen pamabrom tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-7001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white (WHITE W RED AND GREEN SPOTS) Score no score
    Shape ROUND (FR7) Size 11mm
    Flavor Imprint Code FR7
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-7001-25 250 in 1 BOX 01/02/2017
    1 NDC:0498-7001-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/01/2017
    FEM RELIEF 
    acetaminophen pamabrom tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-7000
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white (WHITE W RED AND GREEN SPOTS) Score no score
    Shape ROUND (FR7) Size 11mm
    Flavor Imprint Code FR7
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-7000-50 250 in 1 BOX 02/15/2012 01/01/2017
    1 NDC:0498-7000-25 125 in 1 BOX
    1 NDC:0498-7000-10 50 in 1 BOX
    1 NDC:0498-7000-01 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 02/15/2012 01/01/2017
    Labeler - North Safety Products LLC (019777263)
    Registrant - North Safety Products LLC (019777263)
    Establishment
    Name Address ID/FEI Business Operations
    North Safety Products LLC 019777263 repack(0498-7000, 0498-7001)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 pack(0498-7000, 0498-7001)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(0498-7000, 0498-7001)