QC PINK BISMUTH- bismuth subsalicylate tablet, film coated

QC Pink Bismuth by

Drug Labeling and Warnings

QC Pink Bismuth 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]

Drug Facts

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

PURPOSE

Purpose

Upset stomach reliever and anti-diarrheal

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 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

• ▪ swallow with water, do not chew
• ▪ adults and children 12 years and older: 2 caplets every 1/2 to 1 hour as needed
• ▪ do not exceed 8 doses (16 caplets) 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 caplet contains: calcium 27 mg, sodium 3 mg
• ▪ salicylate 99 mg
• ▪ low sodium
• ▪ sugar free
• ▪ store at room temperature.

Questions or comments?

1-866-467-2748

Inactive Ingredients

calcium carbonate, crospovidone, D&C red #27 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.

PRINCIPAL DISPLAY PANEL

NDC# 63868-171-40

Compare to Pepto-Bismol® Regular Strength the active ingredient*

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate 262mg

Upset stomach Indigestion, Nausea, Heartburn, Diarrhea

Package Contains One Bottle

40 Caplets

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 
bismuth subsalicylate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-171
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	V
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-171-40	1 in 1 CARTON	04/15/2019
1		40 in 1 BOTTLE; Type 0: Not a Combination Product

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)