Label: DOXYCYCLINE HYCLATE tablet, film coated

  • NDC Code(s): 24658-310-01, 24658-310-05, 24658-310-07, 24658-310-08, view more
  • Packager: PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 14, 2025

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  • SPL UNCLASSIFIED SECTION
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to ...
  • DESCRIPTION
    Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets for oral administration. The chemical designation of doxycycline is ...
  • CLINICAL PHARMACOLOGY
    Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations and ...
  • INDICATIONS AND USAGE
    To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent ...
  • CONTRAINDICATIONS
    This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
  • WARNINGS
    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 the teeth ...
  • PRECAUTIONS
    General - As with other antibacterial drugs, use of doxycycline hyclate tablets may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, doxycycline ...
  • ADVERSE REACTIONS
    Due to oral doxycycline’s virtually complete absorption, side effects of the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in ...
  • OVERDOSAGE
    In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases ...
  • DOSAGE AND ADMINISTRATION
    The usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side ...
  • HOW SUPPLIED
    Doxycycline hyclate tablets, USP equivalent to 50 mg of doxycycline: Light beige, round convex beveled edge, film-coated tablets debossed “€” above “311” on one side and plain on the ...
  • 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, tetracycline PO4, and methacycline; in ...
  • REFERENCES
    1. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195. 2. Cziezel AE and Rockenbauer M ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg, 50 Tablets
    Epic Doxycycline Hyclate Tablets, USP - 100 mg 50 Tablets - Rx Only
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg 210 Tablets
    Epic Doxycycline Hyclate Tablets, USP - 100 mg 210 Tablets - Rx Only
  • INGREDIENTS AND APPEARANCE
    Product Information