Active Ingredient (In Each Caplet)
Bismuth subsalicylate 262 mg
Stomach Relief Tablet
FDA Label NDC 41226-475
16 label sections · Submitted to the FDA by Kroger · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger for the product Stomach Relief (NDC 41226-475). 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, uses, warnings, do not useif you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you aretaking any drug for, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Upset stomach reliever and antidiarrheal
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 Useif 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 Aretaking 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
If Pregnant Or Breast Feeding,
ask a health professional before use.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- swallow with water, do not chew
- adults and children 12 years and over:
- 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
-2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea
-2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
Other Information
- each caplet contains:calcium 27 mg
- salicylate 99 mg
- low sodium
- store at room temperature
Inactive Ingredients
calcium carbonate, D&C red #27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, silicon dioxide, sodium starch glycolate
Questions Or Comments?
Call 1-800-632-6900
Package Label.Principal Display Panel
Stomach Relief 24 count - Carton and Label
Stomach-relief-24s-label (Stomach Relief 24s Label)
Stomach-relief-24s-ifc (Stomach Relief 24s Ifc)
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