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 subsalicylate 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.

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Active Ingredients

Bismuth Subsalicylate 525 mg

Purpose

Upset Stomach Reliever and Antidiarrheal

Uses

relieves

• traveler's diarrhea
• diarrhea
• upset stomach due to overindulgence 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 and vomiting occur, consult a doctor because there 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, darking of the stool and/or tongue may occur.

Stop use and ask a doctor if

• symptoms get worse or last for more than two days
• 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• drink plenty of clear fluids to help prevent dehydration cause by diarrhea
• shake well before use
• adults and children 12 years of age and over:
• 2 tablespoonfuls (30 mL) every 1/2 hour or 4 tablespoonfuls (60 mL) every hour as needed for diarrhea/traveler's diarrhea  
• 2 tablespoonfuls (30 mL) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• do not exceed 8 doses (16 tablesproonfuls or 240 mL) in 24 hours
• use until diarrhea stops but not more than 2 days
• Children under 12 years: ask a doctor

Inactive ingredients

benzoic acid, citric acid, FD&C yellow #5, flavor, salicylic acid, sodium citrate, sodium salicylate, sorbic acid, sucralose, water, xanthan gum

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

BISMUTINA 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-475
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-475-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	04/01/2021

Labeler - Menper Distributors, Inc. (101947166)

Revised: 4/2021

Document Id: c77f770f-7010-4611-ae60-81850ad46714

34390-5

Set id: 14bbbdbb-87c8-47a9-9147-7e0f1b75c7b9

Version: 1

Effective Time: 20210428