Label: DOXYCYCLINE HYCLATE tablet, coated

  • NDC Code(s): 60505-4382-1, 60505-4382-5, 60505-4382-6, 60505-4384-1, view more
  • Packager: Apotex Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 11, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DOXYCYCLINE HYCLATE TABLETS safely and effectively. See full prescribing information for DOXYCYCLINE HYCLATE TABLETS.  DOXYCYCLINE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Rickettsial Infections - Doxycycline hyclate tablets are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - The usual dosage and frequency of administration of doxycycline hyclate tablets differs from that of the other tetracyclines. Exceeding the ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Doxycycline hyclate tablets, USP 75 mg are light teal, round, biconvex film-coated tablets. Engraved "APO" on one side, "D75" on the other side. Doxycycline hyclate tablets, USP 150 mg are mossy ...
  • 4 CONTRAINDICATIONS
    Doxycycline hyclate tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Tooth Development - The use of doxycycline hyclate tablets during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions have been identified during clinical trials or post-approval use of tetracycline-class drugs, including doxycycline. Because these reactions are reported ...
  • 7 DRUG INTERACTIONS
    7.1 Anticoagulant Drugs - Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Doxycycline hyclate tablets, like other tetracycline-class antibacterial drugs, may cause discoloration deciduous teeth, and reversible inhibition of bone growth ...
  • 10 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 ...
  • 11 DESCRIPTION
    Doxycycline hyclate tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Doxycycline is a tetracycline-class antimicrobial drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics - Absorption - Doxycycline hyclate tablets: Following ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals to evaluate carcinogenic potential of doxycycline hyclate have not been conducted. However, a 2 year ...
  • 15 REFERENCES
    1 Friedman JM, 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Doxycycline hyclate tablets, USP 75 mg are light teal, round, biconvex film-coated tablets. Engraved "APO" on one side, "D75" on the other side. Each 75 mg tablet contains 86.6 mg ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Important Administration and Safety Information for Patients and Caregivers - Advise patients taking ...
  • PATIENT PACKAGE INSERT
    FDA-Approved Patient Labeling - Instructions for Use - DOXYCYCLINE HYCLATE TABLETS, USP - (dox" i sye’ kleen hye’ klate) for oral use - Read this Instructions for Use before you start using ...
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION
    Representative sample of labeling (see HOW SUPPLIED section for complete listing): PRINCIPAL DISPLAY PANEL - 75 mg BOTTLE LABEL - APOTEX CORP., NDC No. 60505-4382-6 - Doxycycline Hyclate Tablets ...
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION
    Representative sample of labeling (see HOW SUPPLIED section for complete listing): PRINCIPAL DISPLAY PANEL - 150 mg BOTTLE LABEL - APOTEX CORP., NDC No. 60505-4384-6 - Doxycycline Hyclate Tablets ...
  • INGREDIENTS AND APPEARANCE
    Product Information