Drug Facts
Active ingredient (in each caplet)
Bismuth subsalicylate 262 mg
Digestive Relief Tablet, Film Coated
FDA Label NDC 21130-125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Digestive Relief (NDC 21130-125). 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:
▪ 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
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 at 1-800-222-1222
Directions
▪ swallow with water, do not chew▪ adults and children 12 years and older: 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: calcium 27 mg, sodium 3 mg▪ salicylate 99 mg▪ low sodium▪ sugar free▪ store at room temperature
Questions Or Comments?
1-866-467-2748
Inactive Ingredients
calcium carbonate, crospovidone, D&C Red No. 27, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.
Package Label.Principal Display Panel
NDC# 21130-125-40
Compare to the active ingredient Pepto-Bismol®*
Digestive Relief
Bismuth Subsalicylate 262 mg
Upset Stomach Reliever/ Antidiarrheal
5 Symptoms Digestive Relief
- Heartburn
- Indigestion
- Nausea
- Upset Stomach
- Diarrhea
40 CAPLETS
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by:
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.
Digestive Relief Bismuth Subsalicylate 262 mg (5346 40gb Label)
* Please review the disclaimer below.
