Label: KAO-BIS- bismuth subsalicylate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 53807-503-08, 53807-503-12, 53807-503-16 - Packager: Rij Pharmaceutical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 30, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablespoon= 15 mL)
- Purpose
- Uses
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Warnings
Reye's syndrome: Children and teenagers who have or are recovering from children 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 of Reye's syndrome, a rare but serious illness.
Allergy alert: Contains salicylate. Do not take if you are
- allergic to salicylates (including aspirin)
- taking other salicylate products
Ask a doctor before use if you have
- fever
- mucus in the stool
- a magnesium-restricted diet
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
- Keep out of reach of children.
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Directions
- shake well before each use
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- repeat dosage every 1/2 to 1 hour as needed
- do not take more than 8 doses in 24 hours
- use until diarrhea stops but not more than 2 days
- adults & children 12 years and over: 2 tablespoons (30 mL)
- children under 12 years: ask a doctor
- Inactive ingredients
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Other information
- Store at room temperature. Protect from freezing and excessive heat (over 40oC or 104oF)
- each tablespoon (15 mL) contains: magnesium 32 mg
- each tablespoon (15 mL) contains: total salicylate 159 mg
- each tablespoon (15 mL) contains: sodium 24 mg
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TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
KAO-BIS
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-503 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg in 15 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM SALICYLATE (UNII: WIQ1H85SYP) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color PINK, pink Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-503-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999 2 NDC:53807-503-12 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999 3 NDC:53807-503-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 03/16/1999 Labeler - Rij Pharmaceutical Corporation (144679156) Establishment Name Address ID/FEI Business Operations Rij Pharmaceutical Corporation 144679156 manufacture(53807-503)
