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Threda

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 262mg in 15mL
Labeler: Menper Distributors, Inc.
NDC Code: 53145-057

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:

  • Heartburn
  • Indigestion
  • Upset Stomach
  • Nausea
  • Diarrhea

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 useifyou 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 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), D&C RED NO. 22, D&C RED NO. 28, SALICYLIC ACID, SODIUM SALICYLATE, SORBIC ACID, SUCRALOSE, WATER

THREDA 
bismuth subsalycilate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-057
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 
METHYLCELLULOSE (100 CPS) 
D&C RED NO. 22 
D&C RED NO. 28 
SODIUM SALICYLATE 
SORBIC ACID 
SUCRALOSE 
SALICYLIC ACID 
WATER 
Packaging
#Item CodePackage Description
1NDC:53145-057-041 BOTTLE in 1 CARTON
1120 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: 09/2013
 
Menper Distributors, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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