Label: OMEPRAZOLE capsule, delayed release
- NDC Code(s): 58602-837-05
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 19, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Use
- Warnings
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Do not use if you have:
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- heartburn with lightheadedness, sweating or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain
These may be signs of a serious condition. See your doctor.
- Ask a doctor before use if you have:
- Ask a doctor or pharmacist before use if you are taking a prescription drug.
- Stop use and ask a doctor if:
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- 14-Day Course of Treatment
- Repeated 14-Day Courses (if needed)
- Other information
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Inactive ingredients
black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], talc, titanium dioxide, triethyl citrate.
- Questions?
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Tips for Managing Heartburn
- Do not lie flat or bend over after eating
- Do not wear tight-fitting clothing around the stomach
- Do not eat before bedtime
- Raise the head of your bed
- Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
- Eat slowly and avoid big meals
- If overweight, lose weight
- Quit smoking
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/22/2009 - PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-837 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color PINK (light pinkish red cap) , WHITE (White to off white body) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code OZM;20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-837-05 1 in 1 CARTON 04/28/2023 1 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213201 04/28/2023 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-837) , MANUFACTURE(58602-837)