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Bismatrol by Aidarex Pharmaceuticals LLC

Medically reviewed on December 13, 2017

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 262mg in 15mL
Labeler: Aidarex Pharmaceuticals LLC
NDC Code: 53217-060

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.

Bismatrol

Active ingredient (in each 15 mL tbsp)

Bismuth subsalicylate 262 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 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 tbsp or 240 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 130 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 and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Principal Display Panel

Bismatrol

soothing, coating action provides

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

compare to the active ingredient in pepto-bismol®

8 FL OZ (236 mL)

KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN SECTION.

BISMATROL 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53217-060(NDC:0904-1313)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH CATION) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
D&C RED NO. 22 
D&C RED NO. 28 
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 
POTASSIUM HYDROXIDE 
WATER 
SACCHARIN SODIUM 
SALICYLIC ACID 
DIMETHICONE 
XANTHAN GUM 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53217-060-01236 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33505/30/2008
Labeler - Aidarex Pharmaceuticals LLC (801503249)

 
Aidarex Pharmaceuticals LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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