Signature Care Upset Stomach Relief
FDA Label NDC 21130-132

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 Signature Care Upset Stomach Relief (NDC 21130-132). 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 active ingredient (in each caplet), purpose, use(s), 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

Active Ingredient (In Each Caplet)

Bismuth subsalicylate 262 mg


Purpose

Upset stomach reliever and anti-diarrheal

Use(S)

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 behaviour 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

  • bloody or black stool
  • an ulcer
  • a bleeding problem

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 of 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 Doctor If

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

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.

Directions

  • swallow caplet(s) with water, do not chew 
  • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) 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 27mg, salicylate 102 mg and sodium 2 mg
  • very low sodium
  • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing
  • store at room temperature, in a dry place

Inactive Ingredients

calcium carbonate, colloidal silicon dioxide, D&C red 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate

Principal Display Panel

Compate to Pepto-Bismol® caplets active ingredient*
NDC 21130-132-28
Signature care
Upset Stomach Relief

BISMUTH SUBSALICYLATE 262 mg

Relief of::
indigestion, heartburn, nausea, diarrhea, upset stomach


40 CAPLETS



172 (172)

172 (172)


* Please review the disclaimer below.