PINK BISMUTH- bismuth subsalicylate suspension

Pink Bismuth by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each 15 mL tablespoon)

Bismuth subsalicylate 262 mg

Purposes

upset stomach reliever and antidiarrheal

Uses

relieves:

• heartburn
• indigestion
• upset stomach
• nausea
• diarrhea

(Also relieves traveler's diarrhea and gas, belching, and fullness due to overindulgence with food and drink.)

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 or 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
• 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.
• adults and children 12 years and over: 1 dose (2 Tbsp 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 Tbsp (15 mL) contains: sodium 5 mg
• low sodium
• sugar free
• salicylate 145 mg
• may not meet USP requirements for pH
• pink colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0121-4803-30 (unit dose cups of 30 mL).
• store at 20° to 25°C (68° to 77°F). Protect from freezing.

Inactive ingredients

D&C Red No. 22, D&C Red No. 28, methyl salicylate, peppermint flavor, potassium sorbate, purified water, salicylic acid, sodium benzoate, sodium saccharin, sodium salicylate, veegum and xanthan gum.

Questions or comments?

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R08/09

PRINCIPAL DISPLAY PANEL - Unit Dose Cup Label

Delivers 30 mL
NDC: 0121-4803-30

P INK
B ISMUTH
(Bismuth Subsalicylate
Oral Suspension)

524 mg/30 mL

SHAKE WELL
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT

A48033001

INGREDIENTS AND APPEARANCE

PINK BISMUTH 
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-4803
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
DOCUSATE SODIUM/SODIUM BENZOATE (UNII: 656HXR6YXN)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-4803-30	4 in 1 CASE	09/20/2009
1		10 in 1 TRAY
1		30 mL in 1 CUP, UNIT-DOSE; 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	09/20/2009

Labeler - Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-4803)