Pepto-Bismol description, usages, side effects, indications, overdosage, supplying and lots more!

Pepto-Bismol

Lil' Drug Store Products, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Pepto-Bismol

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever and antidiarrheal

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

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 or last more than 2 days
  • 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.

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 exceed 8 doses (16 tablets) 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 tablet contains: calcium 140 mg
  • sodium less than 1 mg
  • salicylate 102 mg
  • very low sodium
  • sugar free
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

calcium carbonate, flavor, magnesium stearate, mannitol, povidone, red 27 aluminum lake, saccharin sodium, talc

Questions?

1-800-717-3786

Repackaged and distributed with
permission of manufacturer by:

Lil' Drug Store Products
1201 Continental Place NE
Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

Pepto
BISMOL™

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 SYMPTOM RELIEF

Nausea • Heartburn • Indigestion
Upset Stomach • Diarrhea

4 CHEWABLE
TABLETS

Lil'
DrugStore ®

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

Pepto-Bismol

Bismuth subsalicylate TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66715-9723(NDC:37000-477)
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
POVIDONES
D&C RED NO. 27
ALUMINUM OXIDE
saccharin sodium
talc

Product Characteristics

Color Size Imprint Code Shape
PINK 16 mm Pepto;Bismol ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 POUCH
2 NDC:66715-9723-2 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 2010-09-16


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