OTC Medication Information: Esomeprazole Magnesium

ESOMEPRAZOLE MAGNESIUM — esomeprazole magnesium dihydrate capsule, delayed release
CVS Pharmacy, Inc.

Drug Facts

Active ingredient (in each capsule)

*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

Acid reducer

Uses

  • treats frequent heartburn (occurs 2 or more days a week)
  • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy alert: Do not use if you are allergic to esomeprazole

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

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
  • you need to take more than 1 course of treatment every 4 months
  • you get diarrhea
  • you develop a rash or joint pain

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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)

CVSHealthTM
Treats Frequent Heartburn
May take 1 to 4 days for full effect 24 HOUR
Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
Acid reducer
14 CAPSULES
One 14-day course of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (14 Capsule Container Label)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (14 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
14 CAPSULES
One 14-day Course
of treatment Actual Size

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (14 Capsules Container Carton)
(click image for full-size original)

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-RELEASE

CAPSULES 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 (28 Capsules Container Carton)
(click image for full-size original)

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (42 Capsules Container Carton)
(click image for full-size original)

ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-248
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM CARBONATE
MAGNESIUM OXIDE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
GLYCERYL MONOSTEARATE
POLYSORBATE 80
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
AMMONIA
DEXTROSE, UNSPECIFIED FORM
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERRIC OXIDE YELLOW
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code I81
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-248-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (69842-248-06)
2 NDC:69842-248-08 2 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (69842-248-08)
3 NDC:69842-248-10 3 BOTTLE in 1 CARTON contains a BOTTLE
3 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (69842-248-10)
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 Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (69842-248), MANUFACTURE (69842-248)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917626 API MANUFACTURE (69842-248)

Revised: 09/2019 CVS Pharmacy, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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