Active Ingredient (In Each Softgel Capsule)
Pamabrom USP 50 mg
Pamabrom Capsule, Liquid Filled
FDA Label NDC 35916-1654
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Softgel Healthcare Pvt Ltd for the product Pamabrom (NDC 35916-1654). 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 softgel capsule), purpose, uses, ask a doctor or pharmacist before use if, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach of chlidren, 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 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 Chlidren
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.
* Please review the disclaimer below.
