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NDC 63868-0705-30 QC Pink Bismuth 262 mg/1 Details

QC Pink Bismuth 262 mg/1

QC Pink Bismuth is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by CHAIN DRUG MARKETING ASSOCIATION. 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: 63868-0705-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	63868-0705
Product ID	63868-705_c3449547-ab02-47f6-a2c3-e68f272668a2
Associated GPIs
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 Pink Bismuth
Proprietary Name Suffix	Stomach Relief
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/1
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	CHAIN DRUG MARKETING ASSOCIATION
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 63868-0705-30 (63868070530)

Pricing Information	N/A
NDC Package Code	63868-705-30
Billing NDC	63868070530
Package	5 BLISTER PACK in 1 CARTON (63868-705-30) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2020-02-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 97ee3b4d-28e4-42c4-95c3-e9fb6d99297e Details

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

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
▪: 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 of 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 immediately at 1-800-222-1222

Directions

▪: chew completely or dissolve tablets in mouth.
▪: adults and children 12 years and older: 2 tablets (1 dose) every ½ hour to 1 hour as needed for diarrhea
▪: 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
▪: do not exceed 8 doses (16 tablets) in 24 hours
▪: use until diarrhea stops but not more than 2 days
▪: children under 12 years: ask a doctor
▪: drink plenty clear fluids to help prevent dehydration caused by diarrhea.

Other information

▪: each tablet contains: salicylate 102 mg
▪: store at room temperature.
▪: avoid excessive heat
▪: keep this carton for future reference on full labeling

TAMPER EVIDENT: Do not use if printed inner wrap is broken or missing.

Inactive ingredients

D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

Questions comments?

1-800-935-2362

Principal Display

QUALITY CHOICE®

NDC# 63868-705-30

*Compare to the active ingredient in Pepto-Bismol® Chewables*

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

5 Symptom Digestive Relief

Heartburn

Indigestion

Nausea

Upset Stomach

Diarrhea

Original Flavor

30 Chewable Tablets

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 INC., the distributor of Pepto-Bismol®

INGREDIENTS AND APPEARANCE

QC PINK BISMUTH STOMACH RELIEF

bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-705
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	RP124
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-705-30	5 in 1 CARTON	02/24/2020
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	02/24/2020

Labeler - CHAIN DRUG MARKETING ASSOCIATION (011920774)

Revised: 1/2022

Document Id: c3449547-ab02-47f6-a2c3-e68f272668a2

Set id: 97ee3b4d-28e4-42c4-95c3-e9fb6d99297e

Version: 3

Effective Time: 20220118