Label: ESOMEPRAZOLE MAGNESIUM tablet, delayed release
- NDC Code(s): 58602-840-05, 58602-840-61, 58602-840-62
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 12, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- 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
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- adults 18 years of age and older
- this product is to be used once a day (every 24 hours), every day for 14 days
- may take 1 to 4 days for full effect
14-Day Course of Treatment
- swallow 1 tablet with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 tablet a day
- swallow whole. Do not crush or chew tablets.
- do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
- children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
Other information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20° to 25°C (68° to 77°F)
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Inactive ingredients
colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.
Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
Tips for Managing Heartburn
- Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
- Eat slowly and do not eat big meals.
- Do not eat late at night or just before bedtime.
- Do not lie flat or bend over soon after eating.
- Raise the head of your bed.
- Wear loose-fitting clothing around your stomach.
- If you are overweight, lose weight.
- If you smoke, 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 Tablets)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)
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INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-840 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) HYDROXYPROPYL CELLULOSE (20000 WAMW) (UNII: KZQ570MOA5) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW) (UNII: 7773C1ROEU) MAGNESIUM CARBONATE (UNII: 0E53J927NA) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MICROCRYSTALLINE CELLULOSE 301 (UNII: W7YXH6D4BD) MICROCRYSTALLINE CELLULOSE 302 (UNII: 91B875MM4H) GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color PINK (Light pink) Score no score Shape OVAL (Oblong, Biconvex) Size 13mm Flavor Imprint Code K;12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-840-05 1 in 1 CARTON 07/12/2023 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-840-61 2 in 1 CARTON 07/12/2023 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-840-62 3 in 1 CARTON 07/12/2023 3 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 ANDA214473 07/12/2023 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-840) , MANUFACTURE(58602-840)