Label: PAMABROM capsule, liquid filled
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated November 24, 2020
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
Read all package direction 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 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.
- INDICATIONS & USAGE
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.
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
pamabrom capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0795 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 WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) POVIDONE K30 (UNII: U725QWY32X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL (Oblong) Size 14mm Flavor Imprint Code 795 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0795-84 48 in 1 BOTTLE; Type 0: Not a Combination Product 11/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/24/2020 Labeler - WALGREENS CO. (008965063)