REXALL BISMUTH- bismuth subsalicylate suspension 
Dolgencorp, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dolgencorp, LLC Bismuth Drug Facts

Active ingredient (in each 30 mL)

Bismuth subsalicylate 1050 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

travelers’ diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
heartburn
indigestion
nausea
gas
belching
fullness

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 (1-800-222-1222).

Directions

shake well before use
only use the dose cup provided
adults and children 12 years and over: 1 dose (30 mL) every hour as needed
do not exceed 4 doses (120 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 30 mL contains: magnesium 15 mg, potassium 5 mg and sodium 12 mg
salicylate 461 mg
low sodium
store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).
protect from freezing
does not meet USP requirements for pH
for health information visit www.more-info.info

Inactive ingredients

D&C red #22, D&C red #28, magnesium aluminum silicate, methyl salicylate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Principal Display Panel

MAXIMUM STRENGTH

Bismuth

Bismuth subsalicylate 1050 mg per 30 mL

Upset stomach reliever / Antidiarrheal

Soothing relief for:

Indigestion

Upset stomach

Diarrhea

Heartburn

Nausea

GLUTEN FREE

12 FL OZ (355 mL)

Rexall Bismuth image
REXALL BISMUTH 
bismuth subsalicylate suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-337
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 1050 mg  in 30 mL
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
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:55910-337-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part335 09/06/2012
Labeler - Dolgencorp, LLC (068331990)

Revised: 7/2016
Document Id: dbba868d-4df7-4152-8492-4055a847aaa1
Set id: 583a26d5-7c88-49af-b034-099cea077fe5
Version: 3
Effective Time: 20160714
 
Dolgencorp, LLC