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

Pepto-Bismol

Procter & Gamble Manufacturing Company

  • 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 15 ml Tablespoon)

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

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

  • diarrhea lasts more than 2 days
  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs

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

  • 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

Other information

  • each Tbsp contains: sodium 6 mg
  • salicylate 118 mg
  • protect from freezing
  • sugar free
  • avoid excessive heat (over 104°F or 40°C)
  • low sodium
  • TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken.

Inactive ingredients

benzoic acid, flavor, magnesium aluminum silicate, methylcellulose, red 22, red 28, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

Questions?

1-800-717-3786

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

NDC 37000-475-08

Pepto-
BISMOL™

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

5 SYMPTOM RELIEF
Nausea ∙ Heartburn ∙ Indigestion
Upset Stomach ∙ Diarrhea

CHERRY

8 FL OZ (236 mL)

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

Pepto-Bismol

Bismuth subsalicylate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37000-475
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bismuth Subsalicylate BISMUTH CATION 525 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
magnesium aluminum silicate
D&C RED NO. 22
D&C RED NO. 28
SACCHARIN SODIUM DIHYDRATE
Salicylic Acid
SODIUM SALICYLATE
sorbic acid
Sucralose
water

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37000-475-04 118 in 1 BOTTLE, PLASTIC
2 NDC:37000-475-08 236 in 1 BOTTLE, PLASTIC
3 NDC:37000-475-12 354 in 1 BOTTLE, PLASTIC
4 NDC:37000-475-16 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 2004-06-30


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