Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release
- NDC Code(s): 69842-248-06, 69842-248-08, 69842-248-10
- Packager: CVS Pharmacy, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
-
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 capsule with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 capsule a day
- swallow whole. Do not crush or chew capsules.
- 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 20-25°C (68-77°F)
- Meets USP dissolution test 2
-
Inactive ingredients
colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, 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)
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, Rl 02895
©2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India
Code: TS/DRUGS/22/2009 - PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Label)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Carton)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (28 Capsules Container Carton)
CVSHealthTM
Compare to the active
ingredient in Nexium® 24 HR**
Treats Frequent Heartburn
May take 1 to 4 days for full effect 24 HOUR
Esomeprazole Magnesium
DELAYED-RELEASECAPSULES USP 20 mg*
Acid Reducer
See new warning information
28 CAPSULES
(2 bottles of 14 each)
Two 14-day courses of treatment Actual Size
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Capsules Container Carton)
CVSHealthTM
Compare to the active
ingredient in Nexium® 24 HR**
Treats Frequent Heartburn
May take 1 to 4 days for full effect 24 HOUR
Esomeprazole Magnesium
DELAYED-RELEASE
CAPSULES USP 20 mg*Acid reducer
See new warning information
42 CAPSULES
(3 bottles of 14 each)
Three 14-day courses of treatment Actual Size
-
INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-248 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM CARBONATE (UNII: 0E53J927NA) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) AMMONIA (UNII: 5138Q19F1X) 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 WHITE Score no score Shape CAPSULE Size 14mm Flavor Imprint Code I81 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-248-06 1 in 1 CARTON 07/09/2019 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69842-248-08 2 in 1 CARTON 07/09/2019 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69842-248-10 3 in 1 CARTON 07/09/2019 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 ANDA209339 07/09/2019 Labeler - CVS Pharmacy, Inc. (062312574) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(69842-248) , MANUFACTURE(69842-248)
