Active Ingredient(In Each 30 Ml)
Bismuth subsalicylate 525 mg
Stomach Relief Liquid
FDA Label NDC 69256-527
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter, Llc for the product Stomach Relief (NDC 69256-527). 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 30 ml), 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
Purpose
Upset stomach reliever and anti-diarrheal
Use(S)
relieves:
- diarrhea
- heartburn
- indigestion
- nausea
- 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 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
- bloody or black stool
- 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 immediately.
Directions
- shake well before use
- mL = milliliter
- TBSP = tablespoon
- adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
- do not exceed 8 doses (16 TBSP or 240 mL) in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years: ask a doctor
- drink plenty of fluids to help prevent dehydration caused by diarrhea
Other Information
- each 30 mL or 2 TBSP contains:
- potassium 25 mg
- salicylate 260 mg
- sodium 8 mg
- protect from freezing
- avoid excessive heat (over 104oF or 40oC)
- dosage cup provided
Inactive Ingredients
benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum
Principal Display Panel
Harris Teeter™
NDC 69256-527-04
STOMACH RELIEF
BISMUTH SUBSALICYLATE LIQUID
Upset Stomach Reliever/Antidiarrheal
Each 30mL contains:
525 mg bismuth subsalicylate
5-Symptom Digestive Relief:
- Heartburn
- Indigestion
- Nausea
- Diarrhea
- Upset stomach
- Heartburn
- Indigestion
- Nausea
- Diarrhea
- Upset stomach
Compare to active ingredient of Pepto-Bismol*
Original Flavor
8 FL OZ (236 mL)
527-8-ht.jpg (527 8 Ht)
Harris Teeter™
NDC 69256-527-05
STOMACH RELIEF
BISMUTH SUBSALICYLATE LIQUID
Upset Stomach Reliever/Antidiarrheal
Each 30mL contains:
525 mg bismuth subsalicylate
5-Symptom Digestive Relief:
Compare to active ingredient of Pepto-Bismol*
Original Flavor
12 FL OZ (354 mL)
527-12-ht.jpg (527 12 Ht)
* Please review the disclaimer below.
