QC STOMACH RELIEF CHERRY FLAVOR- bismuth subsalicylate suspension

QC Stomach Relief by

Drug Labeling and Warnings

QC Stomach Relief by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 525 mg

Purposes

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

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 or 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 (1-800-222-1222).

Directions

• shake well before use
• for accurate dosing, use dose cup
• adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
• do not exceed 8 doses (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 clear fluids to help prevent dehydration caused by diarrhea

Other information

• each 30 mL contains: sodium 10 mg
• salicylate 261 mg
• low sodium
• sugar free
• store at room temperature
• protect from freezing
• avoid excessive heat (more than 104°F 40°C)

Inactive ingredients

carboxymethylcellulose sodium, D&C Red # 22, D&C Red # 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

Do not use if imprinted shrink band is missing or broken.

Principal Display Panel

Quality Choice®

NDC# 63868-305-08

Compare To the Active Ingredient PEPTO-BISMOL® Regular Strength

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate 525 mg

Soothing Relief from:

Upset Stomach

Indigestion

Nausea

Heartburn

Diarrhea

Regular Strength

Cherry Flavor

8 FL. OZ. (236 mL)

100% QC SATISFACTION GURANTEE

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by The Procter & Gamble, distributor of Pepto-Bismol®.

INGREDIENTS AND APPEARANCE

QC STOMACH RELIEF  CHERRY FLAVOR
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-305
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK (viscous)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-305-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	04/15/2019

Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)