Label: TETRACYCLINE HYDROCHLORIDE capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 12, 2024

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  • SPL UNCLASSIFIED SECTION
    For Oral Use - Rx only - To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride ...
  • DESCRIPTION
    Tetracycline is a yellow crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly ...
  • CLINICAL PHARMACOLOGY
    Tetracyclines are readily absorbed and are bound to plasma protein in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in ...
  • INDICATIONS AND USAGE
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to ...
  • CONTRAINDICATIONS
    This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
  • WARNINGS
    Tooth Development - The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of ...
  • PRECAUTIONS
    General - As with other antibacterials, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue antibacterial and institute ...
  • ADVERSE REACTIONS
    Gastrointestinal: anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with Candida overgrowth) in the ...
  • OVERDOSAGE
    In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracycline is not dialyzable.
  • DOSAGE AND ADMINISTRATION
    Adults - Usual daily dose, 1 gram as 500 mg twice a day or 250 mg four times a day. Higher doses such as 500 mg four times a day may be required for severe infections or for those infections ...
  • HOW SUPPLIED
    Tetracycline Hydrochloride Capsules, USP are available as: 250 mg: Blue opaque cap and yellow opaque Body, size '2', cap and body imprinted B906 in black Ink. NDC: 71335-2415-1: 20 CAPSULEs in a ...
  • ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY
    Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, minocycline, tetracycline PO4 and ...
  • SPL UNCLASSIFIED SECTION
    Rx only - Manufactured by: Cohance Lifesciences Limited - Plot No. A-19/C, A-23A & A-23B, Road No.18, IDA Nacharam, Uppal Mandal, Medchal- Malkajgiri District -500 076, Telangana state ...
  • PRINCIPAL DISPLAY PANEL
    Tetracycline HCL 250mg Capsule
  • INGREDIENTS AND APPEARANCE
    Product Information