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Drug Facts
Midol Bloat Relief Tablet
FDA Label NDC 0280-0070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Midol Bloat Relief (NDC 0280-0070). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, indications & usage, warnings, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each caplet) Purpose
Pamabrom 50 mg……….……………………………………….…...Diuretic
Indications & Usage
Uses for the temporary relief of:
• bloating
• water-weight gain
• swelling
• full feeling associated with the premenstrual and menstrual periods
Warnings
Warnings
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
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
Otc - 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
* Please review the disclaimer below.
