Label: API GENERAL CURE- metronidazole praziquantel powder

  • NDC Code(s): 17163-015-16
  • Packager: MARS FISHCARE NORTH AMERICA, INC.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 30, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients: 250 mg Metronidazole and 75 mg Praziquantel per packet.

  • DOSAGE & ADMINISTRATION

    Directions for Use:

    For best results, remove activated carbon or filter cartridge from filter and continue aeration.

    For each 10 gallons (38 L) of water, empty one packet directly into aquarium.

    Repeat dose after 48 hours.

    Wait another 48 hours then change 25% of the aquarium water and add fresh activated carbon or replace filter cartridge.

    This package treats up to 100 gallons.

    Two doses required for full course of treatment.

    Will not discolor water

    Safe for use with live plants.


  • INDICATIONS & USAGE

    Diagnostic Chart

    Gill and Skin Flukes:

    Very common fish parasite. Can be found on the gills, scales or skin. Not visible without the aid of magnification. Symptoms may include: darkening of skin, clamped fins, excess mucous. Fish may also swim erratically or become emaciated.

    Hole-in-the-Head Disease:

    Symptoms include pitting and erosion of skin and muscle tissue around the face and side of body. Many infected fish exhibit poor appetite, weight loss and nervousness.

    Wasting Disease:

    Fish parasites transmitted from fish to fish cause emaciation, anemia and lethargy. Tissue damage leading to subsequent ulceration of the gastrointestinal tract. Excess mucus and white stringy feces are often produced as a result of parasitic invasion.

    Swollen Abdomen:

    Fish infected with tapeworms (cestodes), often have an extended or swollen abdomen. Internal areas of attachment results in damaged tissue. Fish normally show signs of reduction in growth and general malaise.

  • WARNINGS AND PRECAUTIONS

    KEEP OUT OF THE REACH OF CHILDREN.

    For aquarium use only.

    Not for human consumption or for the treatment of fish intended for human consumption.

    Avoid contact with skin and eyes.

    May cause irritation.

    ! WARNING:

    This product can expose you to chemicals including Metronidazole, which is known to the State of California to cause cancer.

    For more information go to www.P65Warnings.ca.gov.

  • PRINCIPAL DISPLAY PANEL

    Diagnostic Chart

    On Back

    10

    Powder

    Packets

    Use In Fresh and Saltwater Aquariums

    API

    GENERAL CURE

    TREATS PARASITIC FISH DISEASE

    Eliminates a wide variety of parasites

    Fast acting

    Gill and Skin Flukes

    Hole-in-the-Head

    Swollen Abdomen

    Wasting Disease

    GUIDE

    Fish Problem

    Solving

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  • INGREDIENTS AND APPEARANCE
    API GENERAL CURE 
    metronidazole praziquantel powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17163-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E) METRONIDAZOLE250 mg  in 2 g
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL75 mg  in 2 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17163-015-1610 in 1 BOX
    12 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/03/2011
    Labeler - MARS FISHCARE NORTH AMERICA, INC. (049630700)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARS FISHCARE NORTH AMERICA, INC.049630700manufacture, relabel, repack