Label: BISMUTH SUBSALICYLATE capsule, liquid filled
- NDC Code(s): 35916-0234-1
- Packager: Softgel Healthcare Pvt Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 27, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
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Warnings
Reye’s syndrome:
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign Reye’s syndrome, a rare but serious illness.
- Allergy alert:
- Do not use if
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast feeding,
- Keep out of reach of children.
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Directions
- swallow with water, do not chew
- adults and children 12 years and over:
- 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
- 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 16 softgels in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BISMUTH SUBSALICYLATE
bismuth subsalicylate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35916-0234 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) GELATIN (UNII: 2G86QN327L) POVIDONE (UNII: FZ989GH94E) SORBITOL (UNII: 506T60A25R) Product Characteristics Color pink (Opaque) Score no score Shape CAPSULE (oblong) Size 21mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35916-0234-1 1 in 1 CARTON 05/27/2024 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 05/27/2024 Labeler - Softgel Healthcare Pvt Ltd (675584180)