BISMATROL- bismuth subsalicylate liquid

Bismatrol by

Drug Labeling and Warnings

Bismatrol by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL tbsp)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and anti-diarrheal

KEEP OUT OF REACH OF CHILDREN

Uses

relieves:

• diarrhea
• heartburn
• indigestion
• nausea
• upset stomach associated with these symptoms

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
• an ulcer
• a bleeding problem
  

Ask a doctor before use if you have

• fever
• mucus in the stool
  

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  immediately.

Directions

• shake well before use
• for accurate dosing, use dose cup
• adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every hour as needed
• do not exceed 4 doses (8 tbsp or 120 mL) 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

• each Tbsp contains: sodium 5 mg, salicylate 236 mg, potassium 15 mg
• protect from freezing
• avoid excessive heat (over 104oF or 40oC)
• TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken.
  

Inactive ingredients

benzoic acid, D&C red 22, D&C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Principal Display Panel

Maximum Strength Bismatrol

Soothing, coating action provides

fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea

compare to the active ingredient in pepto-bismol® maximum strength

8 FL OZ (236 mL)

Maximum Strength Bismatrol

INGREDIENTS AND APPEARANCE

BISMATROL  
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-1314
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	525 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-1314-09	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	01/05/2009

Labeler - Major Pharmaceuticals (191427277)

Registrant - Guardian Drug Company (119210276)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	manufacture(0904-1314)