FISH SULFA FORTE- sulfamethoxazole, trimethoprim tablet, for solution

FISH SULFA FORTE by

Drug Labeling and Warnings

FISH SULFA FORTE by is a Animal medication manufactured, distributed, or labeled by Thomas Labs, LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Active Ingredients (in each tablet):
Sulfamethoxazole 800mg
Trimethoprim 160mg

Distributed by:

Thomas Labs

Tolleson, AZ 85353

ThomasLabs.com

SPL UNCLASSIFIED SECTION

Fish Sulfa Forte (Sulfamethoxazole/Trimethoprim or SMZ-TMP) is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. It is useful for control of some common bacterial diseases in fish, including diseases caused by bacteria such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).

Directions:

Add 1 tablet (960 mg) into aquarium for every 40 gallons of water to be treated. Repeat in 24 hours. It is suggested that a partial water change be made between treatments. While duration of treatment depends on type and severity of infection, it is recommended that extended medication baths continue for a minimum of 5 days but not more than 10 days. Discontinue treatment if no improvement is noted within 5 days. To remove harmless yellow color, change 20% of water and use charcoal filter until clear.

Warnings:

For aquarium and ornamental fish only. Not for human use. This product should not be given to fish intended for human consumption. Keep out of the reach of children and animals. In case of accidental overdose, contact a health professional immediately.

Storage:

Keep container tightly closed and in a cool, dry place.

Package Labeling:

INGREDIENTS AND APPEARANCE

FISH SULFA FORTE 
sulfamethoxazole, trimethoprim tablet, for solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86024-022
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV)	SULFAMETHOXAZOLE	800 mg
TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)	TRIMETHOPRIM	160 mg

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	H49
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86024-022-30	30 in 1 BOTTLE
2	NDC: 86024-022-10	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/31/2017

Labeler - Thomas Labs, LLC (068824721)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917647	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Thomas Labs, LLC		068824721	repack