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NDC 63868-0303-08 QC Quality Choice Pink Bismuth Stomach Relief 262 mg/15mL Details

QC Quality Choice Pink Bismuth Stomach Relief 262 mg/15mL

QC Quality Choice Pink Bismuth Stomach Relief is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Manufacturing Assn. The primary component is BISMUTH SUBSALICYLATE.

MedlinePlus Drug Summary

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Related Packages: 63868-0303-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	63868-0303
Product ID	63868-303_62c787aa-ab2f-41ab-9eb8-1eec83c48fd0
Associated GPIs	47300010001805
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	QC Quality Choice Pink Bismuth Stomach Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/15mL
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	Chain Drug Manufacturing Assn
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63868-0303-08 (63868030308)

Pricing Information	N/A
NDC Package Code	63868-303-08
Billing NDC	63868030308
Package	236 mL in 1 BOTTLE, PLASTIC (63868-303-08)
Marketing Start Date	2015-03-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a23ac67d-bb35-4778-8ac3-a52078368942 Details

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 ½ to 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 - 236 mL Bottle Label

Quality Choice®

NDC 63868-303-08

*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
NaN: Original Flavor

8 FL OZ (236 mL)

QC SATISFACTION GUARANTEED

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®.

Quality Choice Pink Bismuth Stomach Relief Original flavor 8 FL OZ 236mL

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bismuth subsalicylate (UNII: 62TEY51RR1) (Salicylic acid - UNII:O414PZ4LPZ, Bismuth cation - UNII:ZS9CD1I8YE)	Bismuth subsalicylate	262 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-303-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/23/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	03/23/2015

Labeler - Chain Drug Manufacturing Assn (011920774)

Revised: 1/2022

Document Id: 62c787aa-ab2f-41ab-9eb8-1eec83c48fd0

Set id: a23ac67d-bb35-4778-8ac3-a52078368942

Version: 3

Effective Time: 20220118