PINK BISMUTH- bismuth subsalicylate liquid

PINK BISMUTH by

Drug Labeling and Warnings

PINK BISMUTH by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, GCP Laboratories, GCP LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL tablespoon=TBSP)

Bismuth subsalicylate 262 mg

Purposes

upset stomach reliever and antidiarrheal

Uses

• relieves upset stomach due to overindulgence in food and drink
• controls 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 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 using

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• for accurate dosing, use dose cup

adults and children 12 years and over

• take 2 TBSP every 1/2 hour to 1 hour as needed
• do not exceed 16 TBSP in 24 hours
• use until diarrhea stops but not more than 2 days
  children under 12 years:

ask a doctor

Other information

• each TBSP contains: sodium 6 mg. salicylate 130mg
• protect from freezing
• avoid excessive heat (over 104F or 40C)
  
• store at room temperature
•   TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.
• for health information visit www.info-xtra.com for health information

Inactive ingredients

benzoic acid, D and C red no. 22, D and C red no. 28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicyclic acid, simethicone emulsion, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

Call 1-800-645-2158, 9 am - 5 pm ET, Monday-Friday

package Label

INGREDIENTS AND APPEARANCE

PINK BISMUTH 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1810
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYL SALICYLATE (UNII: LAV5U5022Y)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1810-59	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2012	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	04/01/2012	11/01/2019

Labeler - RUGBY LABORATORIES (079246066)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP LABORATORIES		965480861	manufacture(0536-1810)