GNP PINK BISMUTH- bismuth subsalicylate tablet

GNP Pink Bismuth by

Drug Labeling and Warnings

GNP Pink Bismuth by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per caplet)

Purpose

Upset stomach reliever and anti-diarrheal

KEEP OUT OF REACH OF CHILDREN

Uses

relieves:

• indigestion
• nausea
• heartburn
• diarrhea
• upset stomach associated with these symptoms

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

• bloody or black stool
• an ulcer
• a bleeding problem

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
• 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.

Directions

• Swallow caplet(s) with water, do not chew
• adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
• do not take more than 8 doses (16 caplets) in 24 hours
• children under 12 years: ask a doctor
• drink plenty of fluids to help prevent dehydration which may accompany diarrhea.

Other information

• very low sodium, each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg.
• TAMPER EVIDENT: Do not use if printed seal under cap is torn or missing.
• store at room temperature, in a dry place

Inactive ingredients

calcium carbonate, colloidal silicon dioxide, D&C red 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

PDP

Good Neighbor Pharmacy

COMPARE TO PEPTO-BISMOL® ACTIVE INGREDIENT

protective coating

Pink Bismuth

Soothing relief for: upset stomach, indigestion, nausea, heartburn and diarrhea

40 caplets

INGREDIENTS AND APPEARANCE

GNP PINK BISMUTH 
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-017
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	pink	Score	no score
Shape	capsule	Size	16mm
Flavor		Imprint Code	G172
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24385-017-58	1 in 1 CARTON	08/08/2011
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	08/08/2011

Labeler - Amerisource Bergen (007914906)

Registrant - Guardian Drug Company (119210276)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	manufacture(24385-017)