The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Bismuth Subsalicylate 262 Mg (NDC 69618-029). 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, active ingredient (in each tablet), purposes, uses, 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.
Drug Facts
Allergy alert: Contains salicylates. Do not take if you are:
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Pepto-Bismol®
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
Bismuth subsalicylate 262 mg
Anti-diarrheal / Upset stomach reliever
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.
Do not use
Drug Facts continued on back of label
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 right away.
calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol
call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday
NDC 69618-029-03
Bismuth Subsalicylate
262 mg
UPSET STOMACH RELIEVER / ANTIDIARRHEAL
30 CHEWABLE TABLETS
*compare to Active Ingredients in Pepto-Bismol®
* Please review the disclaimer below.
