PINK BISMUTH- bismuth subsalicylate liquid

Pink Bismuth by

Drug Labeling and Warnings

Pink Bismuth by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 ml Tablespoon)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves

• heartburn
• indigestion
• upset stomach
• 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 vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes 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 (2Tbsp or 30 ml) every 1/2 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 Tspb contains: sodium 9 mg
• salicylate 130 mg
• protect from freezing
• low sodium
• avoid excessive heat (over 104°F or 40°C)
• sugar free
• TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.
  

Inactive ingredients

propylene glycol, sodium benzoate, flavor, magnesium aluminum silicate, methylcellulose, red 40, saccharin sodium, salicylic acid, sodium slicylate, sorbic acid, water, sucrose, xanthan gum

Package label

Pink Bismuth

INGREDIENTS AND APPEARANCE

PINK BISMUTH 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0505
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1)	BISMUTH SUBSALICYLATE	262 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0505-4	120 mL in 1 BOTTLE
2	NDC: 67510-0505-6	177 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	08/29/2011

Labeler - Kareway Product, Inc. (121840057)