ZELCOM- flubendazol tablet

ZELCOM by

Drug Labeling and Warnings

ZELCOM by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Flubendazol

PURPOSE

Flubendazol is an anthelmintic (an-thel-MIN-tik) or anti-worm medication. It prevents newly hatched insect larvae (worms) from growing or multiplying in your body

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

■ adult and children 2 years of age and older: 1 tablet

■ children under 1 years of age: ask a doctor

WARNINGS

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

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

INACTIVE INGREDIENT

cellulose, corn starch, magnesium stearate, sodium starch

DOSAGE & ADMINISTRATION

For oral use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZELCOM 
flubendazol tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72689-0009
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUBENDAZOLE (UNII: R8M46911LR) (FLUBENDAZOLE - UNII:R8M46911LR)	FLUBENDAZOLE	500 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	ZELCOM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72689-0009-1	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/15/2018

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS TRADING		689991468	manufacture(72689-0009)