Pepto-bismol
FDA Label NDC 52904-903

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Pepto-bismol (NDC 52904-903). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, reye's syndrome, allergy alert, do not use if you have, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

PRODUCT REPACKAGED AND DISTRIBUTED WITH
PERMISSION OF MANUFACTURER BY:
Select Corporation Carrollton, TX 75007

Active Ingredient (In Each Tablet)

Bismuth subsalicylate 262 mg

Purpose

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

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

Otc - Ask Doctor

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Otc - When Using

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 & children 12 years & 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, magnesium 9 mg
    • salicylate 101 mg
    • very low sodium
    • avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

1-800-717-3786

Principal Display Panel - 4 Tablet Pouch Blister Pack

Pepto-
Bismol™

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5
SYMPTOM
Digestive Relief

  • heartburn
  • indigestion
  • nausea
  • upset stomach
  • diarrhea

    • 4 Chewable Tablets
    Multi-Pack

    Principal Display Panel (4 Tablet Pouch Blister Pack)

    Principal Display Panel (4 Tablet Pouch Blister Pack)

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