THREDA- bismuth subsalycilate liquid

Threda by

Drug Labeling and Warnings

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

PURPOSE

Purpose
upset stomach reliever and antidiarrheal

INDICATIONS & USAGE

Uses

Relieves:

• Heartburn
• Indigestion
• Upset Stomach
• Nausea
• Diarrhea

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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

DO NOT USE

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 DOCTOR

Ask a doctor before useifyou have

• Fever
• Mucus in the stool

ASK DOCTOR/PHARMACIST

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

• Anticoagulation (thinning the blood)
• Diabetes
• Gout
• Arthritis

WHEN USING

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THREDA 
bismuth subsalycilate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-057
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)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SALICYLIC ACID (UNII: O414PZ4LPZ)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-057-04	1 in 1 CARTON
1		120 mL in 1 BOTTLE

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

Labeler - Menper Distributors, Inc. (101947166)