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

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Bismuth Subsalicylate

A&Z Pharmaceutical, Inc.
A&Z Pharmaceutical, Inc.

Bismuth Subsalicylate 262mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

USES

■ controls diarrhea ■ relives heartburn, indigestion, nausea and upset stomach without constipating

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 stool ■ an ulcer ■ a bleeding problem

Ask a Doctor

before use if you have ■ fever ■ mucus in the stool

Ask a Doctor/Pharmacist before use

are taking any drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis

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

When using this product

a temporary, but harmless, darkening of the stool and/or tongue may occur.

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea ■ Adults and Children 12 years and over: 525 mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hour as needed ■ do not exceed 4200 mg (16 tablets) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ Children under 12 years: ask a doctor

■ save carton for full directions and warnings ■ store at room temperature 59°- 86°F (15°-30°C) ■ do not use if cellophane unit is torn ■ Phenylketonurics: contains phenylalanine 1.1 mg per tablet ■ Calcium content per tablet: 73 mg

aspartame, calcium carbonate, D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide.

DISPLAY PANEL

Bismuth Subsalicylate

Bismuth Subsalicylate TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62211-046(NDC:046)
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
ASPARTAME
CALCIUM CARBONATE
D&C RED NO. 27
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
pink 16 mm AZ046 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62211-046-69 12 in 1 CELLO PACK
2 NDC:62211-046-18 18 in 1 CELLO PACK
3 NDC:62211-046-88 30 in 1 CELLO PACK
4 NDC:62211-046-99 15000 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 2003-03-10


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Be sure to consult your doctor before taking any medication!
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