Active Ingredient (In Each 15 Ml)
Bismuth subsalicylate 525 mg
Qc Stomach Relief Liquid
FDA Label NDC 63868-304
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Qc Stomach Relief (NDC 63868-304). 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 15 ml), purpose, uses, warnings, do not use, 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/Antidiarrheal
Uses
relieves
- travelers' diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- upset stomach
- nausea
- gas
- belching
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
- 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. (1-800-222-1222)
Directions
- shake well before use
- For accurate dosing, use dose cup
- adults and children 12 years and over:
- 1 dose (2 tbsp. or 30 ml) every 1 hour as needed
- do not exceed 4 doses (8tbsp or 120 mL) 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 tbsp. contains: sodium 10 mg
- low sodium
- sugar free
- salicylate 236 mg
- protect from freezing
- avoid excessive heat (more than 104°F or 40°C)
- TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken
Inactive Ingredients
Carboxymethylcellulose sodium, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, red 22, red 28, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum.
Principal Display Panel
Compare to the active ingredient in Pepto-Bismol® Maximum Strength
Pink Bismuth
Maximum Strength
Stomach Relief
Bismuth Subsalicylate 525 mg
Soothing Relief from:
Upset Stomach
Indigestion Nausea
Heartburn
Diarrhea
Original Flavor
FL OZ (mL)
QC SATISFACTION GURANTEED
*This product is not manufactured or distributed by The Procter & Gamble, distributors of Pepto-Bismol®.
Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
Questions: 248-449-9300
Qc(cdma) Maximum Strength Pink Bismuth Subsalicylate525mg (70712qclr.png)
Package Label
Maximum Strength Stomach Relief
* Please review the disclaimer below.
