FDA Label for Quality Choice Ultra Strength Stomach Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 15 ML DOSE)
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Quality Choice Ultra Strength Stomach Relief Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 15 Ml Dose)
Bismuth subsalicylate 525 mg
Purpose
Upset stomach reliever/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 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
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 at 1-800-222-1222.
Directions
- shake well before use
- Only use dose cup provided
- adults and children 12 years and over
- 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea.
- 15 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (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 15 mL dose cup contains:potassium 7 mg, sodium 5 mg
- salicylate 230 mg
- low sodium
- sugar free
- 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, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum.
Principal Display Panel
*Compare to the active ingredient in Pepto-Bismol® Ultra Strength
QUALITY CHOICE
Ultra Strength
Stomach Relief
Bismuth Subsalicylate 525 mg
Upset Stomach Reliever/ Antidiarrheal
Relieves:
Nausea, Heartburn, Indigestion, Upset Stomach & Diarrhea
2X CONCENTRATED FORMULA**
Original Flavor
8 FL OZ (236 mL)
100% QC SATISFACTION GURANTEED
*This product is not manufactured or distributed by The Procter & Gamble, distributors of Pepto-Bismol ®Ultra Strength.
Distributed by CDMA, Inc.
Novi, MI 48375
Questions: 800-935-2362
* Please review the disclaimer below.
