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  5. Label Information: Pepto-bismol

FDA Label for Pepto-bismol

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. REYE'S SYNDROME
    6. ALLERGY ALERT
    7. DO NOT USE IF YOU HAVE
    8. OTC - ASK DOCTOR
    9. OTC - ASK DOCTOR/PHARMACIST
    10. OTC - WHEN USING
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS?
    18. PRINCIPAL DISPLAY PANEL - 4 TABLET POUCH BLISTER PACK

Pepto-bismol Product Label

The following document was submitted to the FDA by the labeler of this product Select Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

* Please review the disclaimer below.