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SPL v2
SPL
SPL Set ID 2d6492e0-1c16-6e3a-e063-6294a90a2440
Route
oral
Published
Effective Date 2025-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bromotheophylline (50 mg)
Inactive Ingredients
fd&c blue no. 1 gelatin, unspecified glycerin polyethylene glycol 400 povidone, unspecified propylene glycol water sorbitol sorbitan titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-07

Purpose

Diuretic

Description

Pamabrom 50 mg


Medication Information

Warnings

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.

Uses

For the relief of

• temporary water weight gain

• bloating • swelling • full feeling associated with the premenstrual and menstrual periods

Purpose

Diuretic

Directions

• Use only as directed.

• Adults: One (1) softgel after breakfast with a full glass of water.

• Dose may be repeated after 6 hours, not to exceed four (4) softgels in 24 hours.

• 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

• store at room temperature between 20°–25°C (68°–77°F)

• protect from light, heat and moisture

Inactive Ingredients

FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Description

Pamabrom 50 mg

Section 42229-5

Compare to the active ingredient in Diurex ®*

CAFFEINE FREE

Fast relief of: 

bloating, swelling, temporary water weight gain associated with the premenstrual and menstrual periods

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Alva-Amco Pharmacal Cos., Inc. the owner of the registered trademark Diurex®.

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get  medical help or contact a Poison Control  Center right away. Prompt medical attention  is critical for adults as well as children even  if you do not notice any signs or symptoms.

Packaging

Drug Facts

Active Ingredient 

Pamabrom 50 mg

Questions Or Comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST


Structured Label Content

Warnings

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.

Uses

For the relief of

• temporary water weight gain

• bloating • swelling • full feeling associated with the premenstrual and menstrual periods

Purpose

Diuretic

Directions

• Use only as directed.

• Adults: One (1) softgel after breakfast with a full glass of water.

• Dose may be repeated after 6 hours, not to exceed four (4) softgels in 24 hours.

• 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 (Other information)

• store at room temperature between 20°–25°C (68°–77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Section 42229-5 (42229-5)

Compare to the active ingredient in Diurex ®*

CAFFEINE FREE

Fast relief of: 

bloating, swelling, temporary water weight gain associated with the premenstrual and menstrual periods

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Alva-Amco Pharmacal Cos., Inc. the owner of the registered trademark Diurex®.

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get  medical help or contact a Poison Control  Center right away. Prompt medical attention  is critical for adults as well as children even  if you do not notice any signs or symptoms.

Packaging

Drug Facts

Active Ingredient  (Active ingredient )

Pamabrom 50 mg

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday 8am - 4pm EST


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)