Pamabrom by SOFTGEL HEALTHCARE PRIVATE LIMITED PAMABROM CAPSULES 50 MG

Pamabrom by

Drug Labeling and Warnings

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

Drug Details [pdf]

PAMABROM- pamabrom capsule, liquid filled 
SOFTGEL HEALTHCARE PRIVATE LIMITED

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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 children

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.

Bottle Label

PAMABROM 
pamabrom capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35916-1653
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM50 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
1,4-SORBITAN (UNII: AV0YTZ4E6J)  
Product Characteristics
Colorblue (Transparent) Scorescore with uneven pieces
ShapeCAPSULE (oval) Size7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35916-1653-148 in 1 BOTTLE; Type 0: Not a Combination Product04/26/202405/08/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02704/26/202405/08/2024
Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-1653)

Revised: 4/2024