Esomeprazole Magnesium
b3d10f0b-52af-408c-9b3d-f8f25f7c42bd
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Acid reducer
Medication Information
Purpose
Acid reducer
Description
Drug Facts
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
Section 42229-5
Drug Facts
Section 50565-1
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).
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Warnings
Allergy alert:
- Do not use if you are allergic to esomeprazole
- Esomeprazole may cause severe skin reactions. Symptoms include:
- skin reddening
- blisters
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
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.
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.
Questions?
Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.
TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing.
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:
Innovus Pharmaceuticals, Inc
Englewood, CO 80112
Other Information
-
•read the directions and warnings before use.
-
•Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.]
-
•keep the carton. It contains important information.
Inactive Ingredients
FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.
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
Active Ingredient (in Each Capsule)
*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)
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.
Principal Display Panel 42 Capsule Bottle Carton
†Compare to active ingredient of Nexium® 24HR
NDC 57483-900-42
C•rcle™
Heartburn
Relief
EsomepraCare®
Esomeprazole Magnesium
Delayed-Release Capsules
20 mg* USP / Acid Reducer
24
hour
Treats Frequent Heartburn
42 CAPSULES
Three 14-Day courses of treatment
May take 1 to 4 days for full effect
TRIPLE PACK 3X14 count bottles inside
Structured Label Content
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
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
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).
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Acid reducer
Warnings
Allergy alert:
- Do not use if you are allergic to esomeprazole
- Esomeprazole may cause severe skin reactions. Symptoms include:
- skin reddening
- blisters
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
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.
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.
Questions?
Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.
TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing.
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:
Innovus Pharmaceuticals, Inc
Englewood, CO 80112
Other Information (Other information)
-
•read the directions and warnings before use.
-
•Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.]
-
•keep the carton. It contains important information.
Inactive Ingredients
FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.
Stop Use and Ask A Doctor If (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
Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))
*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)
Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
-
•taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Principal Display Panel 42 Capsule Bottle Carton (PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton)
†Compare to active ingredient of Nexium® 24HR
NDC 57483-900-42
C•rcle™
Heartburn
Relief
EsomepraCare®
Esomeprazole Magnesium
Delayed-Release Capsules
20 mg* USP / Acid Reducer
24
hour
Treats Frequent Heartburn
42 CAPSULES
Three 14-Day courses of treatment
May take 1 to 4 days for full effect
TRIPLE PACK 3X14 count bottles inside
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:19.939043 · Updated: 2026-03-14T23:04:59.717126