![KAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]](https://medic.hrt.org//dailymed/images/cd0b0192-cd6a-4b4a-bed5-de734372829e/m527.jpg)
| NDC | 53807-503-08, 53807-503-12, 53807-503-16 |
| Set ID | cd0b0192-cd6a-4b4a-bed5-de734372829e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Rij Pharmaceutical Corporation |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART335 |
- Active ingredient (in each tablespoon= 15 mL)
- Purpose
- Uses
-
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.
-
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
-
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
-
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)
