PAMABROM capsule, liquid filled

Pamabrom by

Drug Labeling and Warnings

Pamabrom by is a Otc medication manufactured, distributed, or labeled by Softgel Healthcare Pvt Ltd, SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel capsule)

Pamabrom USP 50 mg

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAMABROM 
pamabrom capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-1654
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	50 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
POVIDONE K30 (UNII: U725QWY32X)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (transparent)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-1654-1	48 in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M027	05/21/2024

Labeler - Softgel Healthcare Pvt Ltd (675584180)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(35916-1654)