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.

----------

Active Ingredient (in each 15 mL tablespoon)
Bismuth Subsalycilate 262 mg

Purpose
upset stomach reliever and antidiarrheal

Uses

Relieves:

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:

Ask a doctor before useifyou have

Ask a doctor or pharmacist before use if you are taking any drug for:

When using this product, a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if:

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

Keep out of the reach of children.

Directions:
Shake well before use
Adult and children 12 years and over: 1 dose (2tbsp or 30 mL) every 1/2 hour as needed, do not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours.

Use until diarrhea stops, but not more than 2 days.
Children under 12 years: ask a doctor
Drink plenty of water or clear fluids to help prevent dehydration caused by diarrhea.

Other Information
Each tablespoon contains: Sodium 6 mg, Low sodium, Sugar free, Salicylate 130 mg. Protect from freezing. Avoid excessive heat (more than 140°F or 40°C)

Tamper-Evident: Do not use if imprinted shrinkband is missing or broken

Inactive ingredients

BENZOIC ACID, MAGNESIUM ALUMINUM SILICATE, METHYLCELLULOSE (100 CPS), FD&C YELLOW #5, SALICYLIC ACID, SODIUM SALICYLATE, SORBIC ACID, SUCRALOSE, WATER, XANTHAN GUM, KAOLIN, SODIUM SACCHARIN

Bismutina Label

BISMUTINA 
bismuth subsalycilate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53145-055
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
MAGNESIUM ALUMINUM SILICATE 
KAOLIN 
FD&C YELLOW NO. 5 
XANTHAN GUM 
SODIUM SALICYLATE 
SORBIC ACID 
SUCRALOSE 
SALICYLIC ACID 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-055-081 in 1 CARTON
1240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33502/21/2012
Labeler - Menper Distributors, Inc. (101947166)

Revised: 9/2013
Document Id: dbe747fb-16c7-4426-b1af-e40daec0ccd4
Set id: 0c793691-4388-40f1-8f61-fb1ca36096f6
Version: 2
Effective Time: 20130919
 
Menper Distributors, Inc.