QC STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid

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 15 mL)

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
  • 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 104ºF or 40ºC)
• 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

www.qualitychoice.com

Questions: 248-449-9300

Package Label

Maximum Strength Stomach Relief

INGREDIENTS AND APPEARANCE

QC STOMACH RELIEF  REGULAR STRENGTH
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-304
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 15 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
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		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-304-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2019
2	NDC: 63868-304-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	04/16/2019

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