Label: PAMABROM capsule, liquid filled
- NDC Code(s): 35916-1654-1
- Packager: Softgel Healthcare Pvt Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 21, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel capsule)
- Purpose
- Uses
- Ask a doctor or pharmacist before use if
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of chlidren
-
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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAMABROM
pamabrom capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35916-1654 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 GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) POVIDONE K30 (UNII: U725QWY32X) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color blue (transparent) Score no score Shape OVAL Size 13mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35916-1654-1 48 in 1 BOTTLE; Type 0: Not a Combination Product 05/21/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M027 05/21/2024 Labeler - Softgel Healthcare Pvt Ltd (675584180) Establishment Name Address ID/FEI Business Operations SOFTGEL HEALTHCARE PRIVATE LIMITED 675584180 manufacture(35916-1654)