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  5. Label Information: Pepto Bismol

FDA Label for Pepto Bismol

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING ANY DRUG FOR
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING,
    12. KEEP OUT OF REACH OF CHILDREN.
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS?
    17. PACKAGE LABELING:

Pepto Bismol Product Label

The following document was submitted to the FDA by the labeler of this product Navajo Manufacturing Company Inc.. 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.

Drug Facts




Active Ingredient (In Each Chewable 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


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

• magnesium 9 mg
• salicylate 101 mg
• very low sodium
• protect from freezing
• avoid excessive heat (over 104°F or 40°C)

• do not use if pouch is opened


Inactive Ingredients



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


Questions?



1-800-717-3786


Package Labeling:



Pepto - Pepto

Pepto - Pepto


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