Label: OMEPRAZOLE capsule, delayed release

  • NDC Code(s): 62175-114-32, 62175-114-37, 62175-114-46, 62175-114-49, view more
  • Packager: Lannett Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 21, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Treatment of Active Duodenal - Ulcer - Omeprazole Delayed-Release Capsules is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Adult Dosage - Regimen by Indication - Table 1 shows the recommended dosage of Omeprazole Delayed-Release Capsules in adult patients by indication. Table 1: Recommended Dosage ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Omeprazole Delayed-Release Capsules, 10 mg, are opaque white cap and opaque white body capsules imprinted with "KU" and "114" in black ink. Omeprazole Delayed-Release Capsules, 20 mg, are opaque ...
  • 4 CONTRAINDICATIONS
    Omeprazole Delayed-Release Capsules is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation [see Warnings and Precautions (5.2)] or any ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Presence of Gastric Malignancy - In adults, symptomatic response to therapy with Omeprazole Delayed-Release Capsules does not preclude the presence of gastric malignancy. Consider additional ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium ...
  • 7 DRUG INTERACTIONS
    Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Omeprazole Delayed-Release Capsules and instructions ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies with Omeprazole Delayed-Release Capsules in pregnant women. Available epidemiologic data fail to demonstrate an ...
  • 10 OVERDOSAGE
    Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included ...
  • 11 DESCRIPTION
    The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In two 24-month carcinogenicity studies in rats, omeprazole at daily doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (about 0.4 to 34 ...
  • 14 CLINICAL STUDIES
    14.1 Active Duodenal Ulcer - In a multicenter, double-blind, placebo-controlled study of 147 patients with endoscopically documented duodenal ulcer, the percentage of patients healed (per ...
  • 15 REFERENCES
    1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition.  CLSI Document ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Omeprazole Delayed-Release Capsules, 10 mg, are opaque white cap and opaque white body capsules imprinted with "KU" and "114" in black ink. They are supplied as follows: Bottles of 30NDC ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Adverse Reactions - Advise patients to report to their healthcare provider if they ...
  • MEDICATION GUIDE
    Dispense with Medication Guide available at: www.lannett.com/med-guide/omeprazole - Omeprazole (oh mep’ ra zole) Delayed-Release Capsules, USP - Read this Medication Guide before you start ...
  • 10 mg bottle label
    Principal Display Panel - 10 mg Bottle Label - NDC 62175-114-32 - Omeprazole - Delayed-Release - Capsules, USP - Print Medication Guides at: www.lannett.com/med-guide/omeprazole - 10 mg - Rx Only - 30 ...
  • 20 mg bottle label
    Principal Display Panel - 20 mg Bottle Label - NDC 62175-118-32 - Omeprazole - Delayed-Release - Capsules, USP - 20 mg - Print Medication Guides at: www.lannett.com/med-guide/omeprazole - Rx Only - 30 ...
  • 40 mg bottle label
    Principal Display Panel - 40 mg Bottle Label - NDC 62175-136-32 - Omeprazole - Delayed-Release - Capsules, USP - 40 mg - Print Medication Guides at: www.lannett.com/med-guide/omeprazole - Rx Only - 30 ...
  • INGREDIENTS AND APPEARANCE
    Product Information