BISMATROL - bismuth subsalicylate liquid 
Major Pharmaceuticals

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.

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Maximum Strength Bismatrol

Active ingredient (in each 15 mL tbsp)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and anti-diarrheal


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 BismatrolBismuth label


BISMATROL  
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1314
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE525 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-1314-09236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/200912/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33501/05/200912/31/2021
Labeler - Major Pharmaceuticals (191427277)
Registrant - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(0904-1314)

Revised: 12/2020
 
Major Pharmaceuticals