Pamabrom Capsules 50 Mg

Pamabrom Capsules 50 Mg
SPL v2
SPL
SPL Set ID 186805ed-84fc-e723-e063-6294a90ad320
Route
ORAL
Published
Effective Date 2024-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bromotheophylline (50 mg)
Inactive Ingredients
Gelatin Glycerin Sorbitol Water Fd&c Blue No. 1 Povidone K30 Polyethylene Glycol 400 Propylene Glycol

Identifiers & Packaging

Pill Appearance
Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-21

Description

Pamabrom USP 50 mg

Purpose

Diuretic


Medication Information

Purpose

Diuretic

Description

Pamabrom USP 50 mg

Uses

For the relief of

temporary water weight gain

bloating

swelling

full feeling associated with the premenstrual and menstrual periods.

Section 51945-4

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.

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 Chlidren

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

Ask A Doctor Or Pharmacist Before Use If

you are taking any other medication.

Active Ingredient (in Each Softgel Capsule)

Pamabrom USP 50 mg


Structured Label Content

Uses

For the relief of

temporary water weight gain

bloating

swelling

full feeling associated with the premenstrual and menstrual periods.

Section 51945-4 (51945-4)

Purpose

Diuretic

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 (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 (Inactive ingredients)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms last for more than ten consecutive days.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Chlidren (Keep out of reach of chlidren)

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

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking any other medication.

Active Ingredient (in Each Softgel Capsule) (Active ingredient (in each softgel capsule))

Pamabrom USP 50 mg


Advanced Ingredient Data


Raw Label Data

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