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Drug Facts
Mckesson Bismuth Tablet, Chewable
FDA Label NDC 68599-4744
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Medical-surgical for the product Mckesson Bismuth (NDC 68599-4744). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each tablet)
Bismuth Subsalicylate 262 mg
(each tablet contains 102 mg salicylate)
Otc - Purpose
Purpose antidiarrheal/antacid
Indications & Usage
Uses
relieves
- traveler's diarrhea
- diarrhea
- upset stomach reliever due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching
• fullness
Warnings
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
Otc - Do Not Use
Do not use if you have
- bloody or black stool
- an ulcer
- a bleeding problem
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 if you are taking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
Otc - When Using
When using this product a temporary and harmless darkening of the tongue and/or stool may occur.
Otc - Stop Use
Stop use and ask a doctor if
- symptoms get worse or lasts 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 accidental overdose, contact a physician or poison control center right away (1-800-222-1222).
Dosage & Administration
Directions
- chew or dissolve in mouth
- drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
- chew 2 tablets every 1/2 to 1 hour as needed
- do not exceed 16 tablets in 24 hours
- use until diarrhea stops but not more than 2 days
Adults and children: (12 years and over)
Children under 12 years:
Ask a doctor
Other Safety Information
Other information
- phenylketonurics: contains phenylalanine 1.1 mg per tablet
- calcium content per tablet: 73 mg
- store at room temperature 59°-86°F (15°-30°C)
- tamper-evident sealed packets
- do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide
Otc - Questions
Questions or comments? 1-800-777-4908
Package Label.Principal Display Panel
NDC 68599-4744-7
McKesson
Bismuth Tablets 262 mg
Bismuth Suybsalicylate
2 Per Pack | 100 Packs Per Box
MFR # 82473
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