Bismatrol description, usages, side effects, indications, overdosage, supplying and lots more!

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Bismatrol

Aidarex Pharmaceuticals LLC

Bismatrol


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 15 mL tbsp)

Bismuth subsalicylate 262 mg

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 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

Bismatrol 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)

Bismatrol

KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN SECTION.

Bismatrol

Bismuth Subsalicylate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53217-060(NDC:0904-1313)
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
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

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53217-060-01 236 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 2008-05-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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