PINK BISMUTH- bismuth subsalicylate liquid

Pink Bismuth by

Drug Labeling and Warnings

Pink Bismuth by is a Otc medication manufactured, distributed, or labeled by We Care Distributor Inc., PURINE PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever/antidiarrheal

Uses

• relieves upset stomach, heartburn, indigestion, nausea, diarrhea

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 vomitting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrom, a rare but serious illness.

Allergy alert:Contains salicylates. Do not take if you are

• taking other salicylate products
• allergic to salicylates (including aspirin) 

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, a sodium-restricted diet, a magnesium restricted diet

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 this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

• Shake well before use
• Use pre-measured cup for accurate dosing. mL = mililiter
• Adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
• Do not take more than 4 doses 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 15 mL contains: Sodium 24 mg, Sugar free, Magnesium 32 mg
• Salicylate 159 mg
• Keep tightly closed
• Avoid excessive heat (over 104°F or 40°C)
• protect from freezing
• store at room temperature
• TEMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive ingredients

carboxymethylcellulose sodium, D&C red #3, FD&C red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium salicylate, sorbitol, water

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

Compare to Original Pepto-Bismol® active ingredient

ORIGINAL STRENGTH

Stomach Relief

Upset Stomach Reliever/Antidiarrheal

Bismuth Subsalicylate 262 mg

Protective Coating Action

Soothing Relief for 5 Symptoms:

Heartburn

Indigestion

Upset Stomach

Nausea

Diarrhea

INGREDIENTS AND APPEARANCE

PINK BISMUTH 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-047
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	PINK (viscous)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-047-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	10/25/2016

Labeler - We Care Distributor Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
PURINE PHARMA LLC		019950491	manufacture(70005-047)