Label: DOXYCYCLINE MONOHYDRATE- doxycycline capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 53002-0671-0, 53002-0671-1, 53002-0671-2, 53002-0671-3, view more - Packager: RPK Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0591-0411
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Drug Label Information
Updated December 24, 2020
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SPL UNCLASSIFIED SECTIONTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Monohydrate Capsules and other antibacterial drugs, Doxycycline Monohydrate Capsules should be ...
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DESCRIPTION
Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline Monohydrate Capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate ...
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CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in ...
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INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Monohydrate Capsules and other antibacterial drugs, Doxycycline Monohydrate Capsules should be used ...
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CONTRAINDICATIONS
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
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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 ...
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PRECAUTIONS
General: As with other antibacterial preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. If superinfection ...
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ADVERSE REACTIONS
Due to oral doxycycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in ...
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OVERDOSAGE
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life, and it would not be of benefit in treating cases of ...
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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 ...
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HOW SUPPLIED
Product: 53002-0671 - NDC: 53002-0671-1 2 CAPSULE in a BOTTLE - NDC: 53002-0671-2 10 CAPSULE in a BOTTLE - NDC: 53002-0671-3 14 CAPSULE in a BOTTLE - NDC: 53002-0671-4 20 CAPSULE in ...
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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 ...
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REFERENCES
1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement, CLSI document ...
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Doxycycline Monohydrate 100mg Capsules
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INGREDIENTS AND APPEARANCEProduct Information