Pink Bismuth

Pharmaceutical Associates, Inc.

Pink Bismuth (Bismuth Subsalicylate Oral Suspension)

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient (in each 15 mL tablespoon)
• Purposes
• Pink Bismuth Uses
• Warnings
  • Reye's syndrome
  • Allergy alert
  • Do not use if you have
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
• Directions
• Other Information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - Unit Dose Cup Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient (in each 15 mL tablespoon)

Bismuth subsalicylate 262 mg

Purposes

upset stomach reliever and antidiarrheal

Pink Bismuth 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

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

PINK
BISMUTH
(Bismuth Subsalicylate
Oral Suspension)

524 mg/30 mL

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

A48033001