BISMUTH- bismuth subsalicylate liquid

Bismuth by

Drug Labeling and Warnings

Bismuth 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

Upset stomach reliever and anti-diarrheal

Uses

• relieves upset stomach due to overindulgence in food or drink
• controls diarrhea

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 of 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

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• shake well before using
• use pre-measured cup for accurate dosing
• 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
• 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

STORAGE AND HANDLING

• Store at room temperature. Protect from freezing and excessive heat (over 40oF or 104oC)
• each tablespoon (15 mL) contains: magnesium 32 mg
• each tablespoon (15 mL) contains: sodium 24 mg
• each tablespoon (15 mL) contains: total salycylate 159 mg
• TAMPER EVIDENT:Do not use if printed inner cap seal is broken or missing..
  

Principal Display Panel

INGREDIENTS AND APPEARANCE

BISMUTH  
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53807-152
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	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53807-152-08	237 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(53807-152)