Label: DEXAMETHASONE tablet

  • NDC Code(s): 71335-2500-0, 71335-2500-1, 71335-2500-2, 71335-2500-3, view more
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 69452-277
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 23, 2024

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  • DESCRIPTION
    Dexamethasone tablets, USP, for oral administration, are supplied as 4 mg, and 6 mg. Inactive ingredients are corn starch, D&C yellow 10 (4 mg), FD&C blue 1 (6 mg), lactose monohydrate, and ...
  • CLINICAL PHARMACOLOGY
    Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In ...
  • INDICATIONS AND USAGE
    Allergic states:Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug ...
  • CONTRAINDICATIONS
    Systemic fungal infections (see - WARNINGS, Fungal infections). Dexamethasone tablets are contraindicated in patients who are hypersensitive to any components of this product.
  • WARNINGS
    General - Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see - ADVERSE REACTIONS). Increased dosage of rapidly acting ...
  • PRECAUTIONS
    General - The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since ...
  • ADVERSE REACTIONS (listed alphabetically, under each subsection)
    The following adverse reactions have been reported with dexamethasone or other corticosteroids: Allergic Reactions:Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular:Bradycardia ...
  • OVERDOSAGE
    Treatment of overdosage is by supportive and symptomatic therapy. In the case of acute overdosage, according to the patient’s condition, supportive therapy may include gastric lavage or ...
  • DOSAGE AND ADMINISTRATION
    For Oral Administration - The initial dosage varies from 0.75 mg to 9 mg a day depending on the disease being treated. It Should Be Emphasized That Dosage Requirements Are Variable and Must Be ...
  • HOW SUPPLIED
    Dexamethasone tablets, USP 4 mg: Pale yellow, round tablets with side notches, a functional score on one side and debossed ‘ S2’ on the other side of the tablet. NDC: 71335-2500-1: 30 Tablets in a ...
  • PRINCIPAL DISPLAY PANEL
    Dexamethasone 4mg Tablet
  • INGREDIENTS AND APPEARANCE
    Product Information