Label: TETROXY HCA- oxytetracycline hcl powder

  • NDC Code(s): 61133-5010-1, 61133-5010-2, 61133-5010-3
  • Packager: Bimeda, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated December 11, 2024

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  • DESCRIPTION

    Tetroxy® HCA-1400
    (oxytetracycline hydrochloride soluble powder)
    Antibiotic
    CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

    This packet contains 512 g of oxytetracycline hydrochloride and will make:
    2560 gallons (9690 liters) containing 200 mg oxytetracycline hydrochloride per gallon
    1280 gallons (4845 liters) containing 400 mg oxytetracycline hydrochloride per gallon
    640 gallons (2422 liters) containing 800 mg oxytetracycline hydrochloride per gallon
    This packet will treat 51,200 lbs of swine.
    This packet will treat 20,480 lbs of turkey at 25 mg/lb body weight.

    For Use in Drinking Water Only
    Not For Use in Liquid Medicated Feeds
    Not For Use in Humans
    Keep Out of Reach of Children
    HAZARDOUS REMEDY
    See back panel for instructions.
    Approved by FDA under ANADA # 200-144

    Net Weight: 3.09 lb (1400 g)

  • DOSAGE & ADMINISTRATION

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  • PRECAUTIONS

    CAUTION: Use as the sole source of oxytetracycline. Not to be used for more than 5 consecutive days in swine or 14 consecutive days in chickens and turkeys.

  • RESIDUE WARNING

    WARNING: Do not feed to birds producing eggs for human consumption.

  • STORAGE AND HANDLING

    RECOMMENDED PACKET STORAGE CONDITIONS: Store between 20°C - 25°C (68°F - 77°F) with excursions permitted between 15°C - 40°C (59°F - 104°F).

    CONTACT INFORMATION: To report adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    TETROXY HCA 
    oxytetracycline hcl powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61133-5010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S) OXYTETRACYCLINE HYDROCHLORIDE648 g  in 1772 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-5010-1280 g in 1 POUCH
    2NDC:61133-5010-21400 g in 1 POUCH
    3NDC:61133-5010-31772 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20014407/02/2004
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda, Inc.060492923manufacture
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