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.

PAMABROM 
pamabrom capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-1653
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
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
Color	blue (Transparent)	Score	score with uneven pieces
Shape	CAPSULE (oval)	Size	7mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-1653-1	48 in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2024	05/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M027	04/26/2024	05/08/2024

Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(35916-1653)

Revised: 4/2024

Document Id: 16d59c0f-5378-028c-e063-6394a90a8342

34390-5

Set id: 15e446f7-aa6f-7d8c-e063-6394a90ac51a

Version: 2

Effective Time: 20240426