Otc - Active Ingredient
Pamabrom 50mg
Pamabrom Capsule, Liquid Filled
FDA Label NDC 0363-0795
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co. for the product Pamabrom (NDC 0363-0795). 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 otc - active ingredient, otc - purpose, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Diuretic
Inactive Ingredient
FD&C Blue#1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol and titanium dioxide
Dosage & Administration
Read all package direction 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 in 24 hours.
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.
Indications & Usage
For the relief of
temporary water wieght gain
bloating
swelling
full feling associated with the premenstrual and menstrual periods
Warnings
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Other Safety Information
Contents sealed: Each clear translucent blue-colored, oval shaped Diuretic softgel capsule bears the identifying mark "795".
Contents packaged ina bottle with a safety seal under cap. Do not use if seal appears broken.
Package Label.Principal Display Panel
Diuretic (Diuretic)
* Please review the disclaimer below.
