FDA.reportPublic FDA data

PAMABROM CAPSULES 50 MG

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2024-04-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:05:12

Label at a glance#

ProductPamabrom
Active ingredientPAMABROM
Label structure11 sections

Indications and uses

For the relief of temporary water weight gain bloating swelling full feeling associated with the premenstrual and menstrual periods

Dosage and administration

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 adul...

Storage and handling

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.

Label contents#

Full prescribing information#

Active ingredient (in each softgel capsule)

OTC - ACTIVE INGREDIENT SECTION

Pamabrom USP 50 mg

Purpose

OTC - PURPOSE SECTION

Diuretic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

you are taking any other medication.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms last for more than ten consecutive days.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle LabelBottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-165335916-1653-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PAMABROMUA8U0KJM72ACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
1,4-SORBITANAV0YTZ4E6JIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
16d59c0f-5378-028c-e063-6394a90a834215e446f7-aa6f-7d8c-e063-6394a90ac51a2024-04-26WarningsExact identifier
spl set id: 15e446f7-aa6f-7d8c-e063-6394a90ac51a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.