Bismutina by Menper Distributors, Inc.

Bismutina by

Drug Labeling and Warnings

Bismutina by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BISMUTINA- bismuth subsalycilate liquid 
Menper Distributors, Inc.

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.

----------

Active Ingredient(in each 15 mL tablespoon)

Bismuth Subsalycilate 262 mg..................................... Upset Stomag reliever and antidiarrheal

Purpose

upset stomach reliever and antidiarrheal

Uses

Relieves:

• Diarrhea
• Upset stomach due to over indulgence in food and drink, including :
• Heartburn
• Indigestion
• Nausea
• gas
• belching 

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 salicilates (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 doctor or pharmacist before use  if you are taking any drugs 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
• diarreah lasts more than 2 days 

if pregnant or breast-feeding 

ask a health professional before use.

keep out of the reach of children 

in case of accidental 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 of age and over: 1 dose (2 tbsp or 30 mL) every 1/2 hours to 1 hour as needed 
• no not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours 
• Use until diarrhea stops, but no more than 2 days.
• Children under 12 years: consult a doctor
• drink prenty of water or clear fluids to help prevent dehydration cause by diarrhea

Other safety information 

• Low sodium
• Sugar free
• Salicylate 130 mg 
• Protect from freezing 
• Avoid excessive heat (more tha 104° F or 40° C)
• Tamper-Evident: Do not use if printed cello-band is torn, broken or missing. 

inactive ingredients 

benzoic acid, FD&C yellow #5, flavor, kaolin, magnesium aluminium silicate,salicylic acid, sodium saccharin, sodium salicylate, sorbic acid, sucralose, sucrose, water, xanthan gum

Questions?

call 1-800-560-5223 M-F 9 AM to 5 PM Eastern Time

BISMUTINA 
bismuth subsalycilate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-055
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-055-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/21/2012	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	02/21/2012	01/01/2020

Labeler - Menper Distributors, Inc. (101947166)

Revised: 4/2020

Document Id: fd5c8571-c34c-4ff6-aa2f-4e960851ec69

34390-5

Set id: 0c793691-4388-40f1-8f61-fb1ca36096f6

Version: 5

Effective Time: 20200418