KAO-BIS- bismuth subsalicylate liquid

Kao-Bis by

Drug Labeling and Warnings

Kao-Bis by is a Otc medication manufactured, distributed, or labeled by Rij Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablespoon= 15 mL)

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal/upset stomach reliever

Uses

• relieves diarrhea
• relieves nausea and upset stomach associated with this symptom

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
  

Do not use

• if you have bloody or black stool
• if you have an ulcer or bleeding problem

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
  

When using this product

a temporary, but harmless darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

• symptoms get worse
• ringing in the ears or loss of hearing occurs
• diarrhea lasts more than 2 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.

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

Carboxymethylcellulose sodium, D&C Red #3, FD&C Red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium saliycylate, sorbitol, water

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

INGREDIENTS AND APPEARANCE

KAO-BIS  
bismuth subsalicylate liquid

Product 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)