Drug Facts
Active ingredient (in each caplet)
Bismuth subsalicylate 262 mg
The following Structured Product Label (SPL) was submitted to the FDA by Leader/ Cardinal Health 110, Inc. for the product Bismuth Subsalicylate (NDC 70000-0594). 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, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each caplet)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever and anti-diarrheal
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
Do not use if you have
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking any drug for
When using this product a temporary but harmless darkening of the stool and/or tongue may occur.
Stop use and ask a doctor if
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 (1-800-222-1222) immediately.
adults and children 12 years and over:
children under 12 years: ask a doctor
croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.
1-800-200-6313
RETAIN THIS CARTON FOR FULL LABELING INFORMATION
WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
COMPARE TO PEPTO-BISMOL active ingredient*
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979
Product of Mexico
* Please review the disclaimer below.