Label: OMEPRAZOLE capsule, delayed release

  • NDC Code(s): 57237-160-01, 57237-160-30, 57237-161-01, 57237-161-30, view more
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 12, 2024

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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 are 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 USP, 10 mg are pink/pink size ‘3’ hard gelatin capsule filled with white to off-white enteric-coated granules and imprinted with ‘E’ on pink cap and ‘65’ on ...
  • 4 CONTRAINDICATIONS
    Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Presence of Gastric Malignancy - In adults, symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic ...
  • 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 difficile-Associated ...
  • 7 DRUG INTERACTIONS
    Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies with omeprazole in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major ...
  • 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, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-­3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a ...
  • 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 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 USP, 10 mg are pink/pink size ‘3’ hard gelatin capsule filled with white to off-white enteric-coated granules and imprinted with ‘E’ on pink cap and ‘65’ on ...
  • 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
    Omeprazole Delayed-Release Capsules, USP - (oh mep' ra zole) Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may ...
  • INSTRUCTIONS FOR USE
    Omeprazole Delayed-Release Capsules, USP - (oh mep' ra zole) Omeprazole delayed-release capsules - Taking omeprazole delayed-release capsules with applesauce: 1. Place 1 tablespoon of ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Capsules Bottle)
    Rising®                             NDC 57237-160-30 - PHARMACEUTICALS - Omeprazole - Delayed-Release - Capsules, USP - 10 mg E -            65 - PHARMACIST: Dispense the - Medication Guide ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (30 Capsules Bottle)
    Rising®                           NDC 57237-161-30 - PHARMACEUTICALS - Omeprazole - Delayed-Release - Capsules, USP - 20 mg  E -             67 - PHARMACIST: Dispense the - Medication Guide ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg (30 Capsules Bottle)
    Rising®                            NDC 57237-162-30 - PHARMACEUTICALS - Omeprazole - Delayed-Release - Capsules, USP - 40 mg  E -             69 - PHARMACIST: Dispense the - Medication Guide ...
  • INGREDIENTS AND APPEARANCE
    Product Information