Label: MIDOL BLOAT RELIEF- pamabrom tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet) Purpose

    Pamabrom 50 mg……….……………………………………….…...Diuretic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses for the temporary relief of:

    • bloating

    • water-weight gain

    • swelling

    • full feeling associated with the premenstrual and menstrual periods

  • WARNINGS

    Warnings

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than the recommended dose
    • adults and children 12 years and older:
      • take 1 caplet with water
      • repeat every 6 hours, as needed
      • do not exceed 4 caplets per day
    • children under 12 years: consult a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • Store between 20°-25°C (68°-77°F).
    • Each caplet contains: 160 mg of Calcium
  • INACTIVE INGREDIENT

    Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium lauryl sulfate, stearic acid, talc, titanium dioxide

  • QUESTIONS

    Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

  • Carton 60 count

    NEW

    Midol®

    Bloat Rlief

    Pamabrom/Diuretic

    RELIEVES BLOATING

    SWELLING - FULL FEELING

    WATER WEIGHT GAIN

    60 CAPLETS

    Midol Bloat Relief Carton 60 count

  • INGREDIENTS AND APPEARANCE
    MIDOL BLOAT RELIEF 
    pamabrom tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0070
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0070-011 in 1 CARTON04/28/2021
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02704/28/2021
    Labeler - Bayer HealthCare LLC. (112117283)
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