FDA.reportPublic FDA data

Pamabrom Capsules 50 mg

Manufacturer
Softgel Healthcare Pvt Ltd
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:51

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 - DO NOT 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 chlidren

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
832080pamabrom 50 MG Oral CapsulePSN2
832080pamabrom 50 MG Oral CapsuleSCD2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130335916165414GTIN-13: 0335916165414
EAN-13: 0335916165414
GTIN-12: 335916165414
UPC-A: 335916165414
GTIN storage (14 digits): 00335916165414		Pamabrom Capsules 50 mg Bottle Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-1654-1Pamabrom48 in 1 BOTTLECAPSULE, LIQUID FILLED482

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-165435916-1654-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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

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
PamabromPAMABROMSoftgel Healthcare Pvt Ltd186805ed-84fc-e723-e063-6294a90ad3202026-01-27WarningsExact identifier
ndc (package): 35916-1654-1
ndc (product): 35916-1654
ndc11 (package): 35916165401
spl id: 4958ad4c-0499-11f0-e063-6394a90a81d1
spl set id: 186805ed-84fc-e723-e063-6294a90ad320

Reported adverse events (FAERS/openFDA)#

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