PAMABROM- pamabrom capsule, liquid filled 
Softgel Healthcare Pvt Ltd

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Pamabrom Capsules 50 mg

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

Other information

Inactive ingredients

Povidone K30, Propylene glycol, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD&C Blue No.1 and Purified water.

Bottle Label

PAMABROM 
pamabrom capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-1654
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM50 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (transparent) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35916-1654-148 in 1 BOTTLE; Type 0: Not a Combination Product05/21/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02705/21/2024
Labeler - Softgel Healthcare Pvt Ltd (675584180)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-1654)

Revised: 5/2024
Document Id: 186805ed-84fd-e723-e063-6294a90ad320
Set id: 186805ed-84fc-e723-e063-6294a90ad320
Version: 1
Effective Time: 20240521
 
Softgel Healthcare Pvt Ltd