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Bismatrol

Aidarex Pharmaceuticals LLC

Major Bismatrol Chewable Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

Purpose

Upset stomach reliever and anti-diarrheal


Bismatrol 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 chicken 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 stools
  • 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

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
Other information: each tablet contains:
  • sodium less than 1 mg
  • salicylate 102 mg
  • calcium 140 mg
  • very low sodium
  • avoid excessive heat (over 104˚F or 40˚C)
  • TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

Inactive ingredients

calcium carbonate, D and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

Principal Display Panel

Bismatrol Chewable Tablets

soothing, coating action provides fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea

compare to the active ingredient in Pepto-Bismol®

30 chewable tablets

Bismatrol

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Bismatrol

Bismuth subsalicylate TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53217-058(NDC:0904-1315)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bismuth Subsalicylate BISMUTH CATION 262 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM CARBONATE
D&C RED NO. 27
MAGNESIUM STEARATE
mannitol
STARCH, CORN
saccharin sodium

Product Characteristics

Color Size Imprint Code Shape
PINK 17 mm GDC122 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53217-058-01 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 2003-01-03


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Be sure to consult your doctor before taking any medication!
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