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Publix Super Markets Inc

Publix Super Markets, Inc. Chewable Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/antidiarrheal

chewable Uses

relieves

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness

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

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

  • fever
  • mucus in the stool
  • kidney stones
  • a calcium-restricted diet

Ask a doctor or pharmacist before use if you are

taking any drug for

  • anticoagulation (thinning 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 right away. (1-800-222-1222)

Directions

  • chew or dissolve tablets in mouth
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • adults and children 12 years and over: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
  • do not exceed 16 tablets in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor

Other information

  • each tablet contains: calcium 265 mg and salicylate 99 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

calcium carbonate, D&C red #27 aluminum lake, FD&C blue #1 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium

Principal Display Panel

STOMACH RELIEF

chewable

BISMUTH SUBSALICYLATE 262mg

ANTIDIARRHEAL

UPSET STOMACH RELIEVER

Soothing relief for:

heartburn

indigestion

upset stomach

nausea

diarrhea

ACTUAL SIZE

Compare to Active Ingredient in Pepto-Bismol® Chewable Tablets

chewable
Chewable Carton Image 1 Chewable Carton Image 2

chewable

Bismuth subsalicylate TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:56062-469
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
MAGNESIUM STEARATE
mannitol
saccharin sodium

Product Characteristics

Color Size Imprint Code Shape
PINK 17 mm L469 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:56062-469-65 5 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 2001-03-15


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Be sure to consult your doctor before taking any medication!
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