Active Ingredient (In Each Caplet)
Pamabrom 50 mg
Pamprin Tablet, Film Coated
FDA Label NDC 71687-3009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Focus Consumer Healthcare, Llc for the product Pamprin (NDC 71687-3009). 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 active ingredient (in each caplet), purpose, uses, warnings, do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Diuretic
Uses
For the temporary relief of
- bloating
- water-weight gain
- swelling
- full feeling
associated with the premenstrual and menstrual periods.
Warnings
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 breastfeeding, 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.
Directions
- do not take more than the recommended dose
- adults and children 12 years and older:
- take 1 caplet with water
- repeated every 6 hours, as needed
- do not exceed 4 caplets per day
- children under 12 years: consult a doctor
Other Information
Each caplet contains: 170 mg of Calcium
Inactive Ingredients
calcium sulfate dihydrate, croscarmellose sodium, dibasic calcium phosphate dihydrate, FDC Blue #1 lake, hypromellose, magnesium stearate, mineral oil, polyethylene glycol, potassium gluconate, riboflavin, sodium lauryl sulfate, stearic acid, talc, titanium dioxide
* Please review the disclaimer below.
