QC QUALITY CHOICE PINK BISMUTH STOMACH RELIEF- bismuth subsalicylate suspension

QC Quality Choice Pink Bismuth Stomach Relief by

Drug Labeling and Warnings

QC Quality Choice Pink Bismuth Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Manufacturing Assn. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(in each 15 ml Tablespoon)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever and 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.

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 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 clear fluids to help prevent dehydration caused by diarrhea

Other information

• ▪ each tbsp contains: sodium 6 mg
  • ▪ low sodium
  • ▪ sugar free
  • ▪ salicylate 130 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 - 354 mL Bottle Label

QC

Quality Choice®

NDC: 63868-303-12

Compare to the active ingredient in PEPTO-BISMOL®Regular Strength

PINK BISMUTH

Stomach Relief

Bismuth Subsalicylate 262mg

Soothing Relief from:

•   Upset Stomach
•   Indigestion Nausea
•   Heartburn

• Diarrhea
•   ORIGINAL FLAVOR

12 FL OZ (354 mL)

QC SATISFACTION GUARANTEED

©Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

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

INGREDIENTS AND APPEARANCE

QC QUALITY CHOICE PINK BISMUTH STOMACH RELIEF 
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-303
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bismuth subsalicylate (UNII: 62TEY51RR1) (Salicylic acid - UNII:O414PZ4LPZ, Bismuth cation - UNII:ZS9CD1I8YE)	Bismuth subsalicylate	262 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	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-303-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	03/20/2015

Labeler - Chain Drug Manufacturing Assn (011920774)