Label: PAMABROM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 15, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Pamabrom 50mg

  • PURPOSE

    Diuretic

  • INACTIVE INGREDIENT

    FD&C Blue#1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol and titanium dioxide

  • DOSAGE & ADMINISTRATION

    Read all package direction and warnings before use.

    Use only as directed.

    Adults: One(1) softgel capsule after breakfast with a full glass of water.

    Dose may be repeated after 6 hours, not to exceed four (4) softgel capsules in 24 hours.

    Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.

    Drink 6 to 8 glasses of water daily.

    For use by normally healthy adults only

    Persons under 18 years of age should use only as directed by a doctor.

  • INDICATIONS & USAGE

    For the relief of

    temporary water wieght gain

    bloating

    swelling

    full feling associated with the premenstrual and menstrual periods

  • WARNINGS

    Ask a doctor or pharmacist before use if you are taking any other medication.

    Stop use and ask a doctor if symptoms last for more than ten consecutive days.

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

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • OTHER SAFETY INFORMATION

    Contents sealed: Each clear translucent blue-colored, oval shaped Diuretic softgel capsule bears the identifying mark "795".

    Contents packaged ina bottle with a safety seal under cap. Do not use if seal appears broken.

  • PRINCIPAL DISPLAY PANEL

    diuretic

  • INGREDIENTS AND APPEARANCE
    PAMABROM 
    pamabrom capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0795
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (Oblong) Size14mm
    FlavorImprint Code 795
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0795-8448 in 1 BOTTLE; Type 0: Not a Combination Product11/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/24/2020
    Labeler - WALGREENS CO. (008965063)