Label: PAMABROM capsule, liquid filled

  • NDC Code(s): 35916-1653-1
  • Packager: SOFTGEL HEALTHCARE PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 16, 2024

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  • Active ingredient (in each softgel capsule)

    Pamabrom USP 50 mg

  • Purpose

    Diuretic

  • Uses

    For the relief of

    • temporary water weight gain
    • bloating
    • swelling
    • full feeling associated with the premenstrual and menstrual periods
  • 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.

  • Directions

    • Read all package directions 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 per day.
    • 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.
  • Other information

    • Contents sealed: Blue transparent, oval shaped softgel capsules filled with clear to pale blue liquid.
    • Contents packaged in a bottle with a safety seal under cap. Do not use if seal appears broken.
  • Inactive ingredients

    Povidone K30, Propylene glycol, Polyethylene Glycol 400 , Gelatin, Glycerin, Sorbitol Sorbitan Solution , FD&C Blue No.1 and Purified water.

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    PAMABROM 
    pamabrom capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-1653
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    1,4-SORBITAN (UNII: AV0YTZ4E6J)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorblue (Transparent) Scorescore with uneven pieces
    ShapeCAPSULE (OVAL) Size7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-1653-148 in 1 BOTTLE; Type 0: Not a Combination Product04/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02704/16/2024
    Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-1653)
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