Drug Facts
Active ingredient (in each caplet)
Bismuth subsalicylate 262 mg
Bismuth Subsalicylate Tablet, Film Coated
FDA Label NDC 69842-346
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Bismuth Subsalicylate (NDC 69842-346). 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 drug facts, otc - purpose, uses, warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Upset stomach reliever and anti-diarrheal
Uses
relieves: ■ indigestion ■ nausea ■ heartburn ■ diarrhea ■ upset stomach associated with these symptoms
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
- 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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center immediately.
Directions
- swallow caplets with water, do not chew
- adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
- do not exceed 8 doses (16 caplets) 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 caplet contains: salicylate 102 mg
- store at room temperature, in a dry place
- TAMPER EVIDENT: do not use if printed seal under cap is torn or missing
Inactive Ingredient
croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.
Other
RETAIN CARTON FOR FULL LABELING INFORMATION
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-30287
Package Label.Principal Display Panel
CVSHealth
Compare to the active ingredient in Pepto-Bismol® Caplets*
Stomach Relief
Bismuth Subsalicylate 262mg
Upset stomach reliever/Antidiarrheal
Soothing relief for 5 symptoms:
• Heartburn
• Indigestion
• Upset stomach
• Nausea
• Diarrhea
Package Contains One Bottle
40 Caplets
* Please review the disclaimer below.
