BISMUTINA- bismuth subsalicylate liquid

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]

ACTIVE INGREDIENT

Active Ingredients

Bismuth Subsalicylate 525 mg

PURPOSE

Purpose

Upset Stomach Reliever and Antidiarrheal

INDICATIONS & USAGE

Uses

relieves

• traveler's diarrhea
• diarrhea
• upset stomach due to overindulgence in food and drink, including:
• heartburn
• indigestion
• nausea
• gas
• belching

WARNINGS

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive ingredients

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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 Drug	M024	04/01/2021

Labeler - Menper Distributors, Inc. (101947166)

Establishment
Name	Address	ID/FEI	Business Operations
RNV, LLC		118917568	manufacture(53145-475)