Esomeprazole Magnesium Delayed-release Capsules 20 Mg - Actavis

Esomeprazole Magnesium Delayed-release Capsules 20 Mg - Actavis
SPL v6
SPL
SPL Set ID 94b3c883-6d6c-4fa8-8430-7f979e6d2a97
Route
ORAL
Published
Effective Date 2024-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Glyceryl Mono And Dipalmitostearate Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Polysorbate 80 Sodium Lauryl Sulfate Sucrose Starch, Corn Talc Titanium Dioxide Triethyl Citrate Crospovidone Hydroxypropyl Cellulose, Unspecified Hydroxypropyl Cellulose, Low Substituted Microcrystalline Cellulose Polyethylene Glycol, Unspecified Propylene Glycol Shellac Sodium Stearyl Fumarate Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: EL Shape: capsule Color: white Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2021-07-23

Description

Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP trihydrate)

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP trihydrate)

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
  • Esomeprazole may cause severe reactions. Symptoms may include:
    • Skin reddening
    • blisters
    • rash

If an allergic reaction occurs, stop use and seek medical help right away.

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 tablet 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.
Package Label
RITE AID Acid Reducer
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)
Inactive Ingredients

black iron oxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid - ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono-and di-glycerides, polyethylene glycol, polysorbate 80, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulfate, sodium stearyl fumarate, sugar spheres (corn starch and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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.

Principal Display Panel

†Compare to the active ingredient in Nexium® 24R

SEE NEW WARNING INFORMATION

TREAT FREQUENT HEARTBURN

ESOMEPRAZOLE MAGNESIUM

Delayed-Release Tablets 20 mg*

Acid Reducer

TABLETS

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Nexium® 24HR.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP BROKEN OR MISSING.

KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

RITE AID

200 NEWBERRY COMMONS

ETTERS, PA 17319

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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Esomeprazole 20 mg

(*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP 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.




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
Purpose

Acid reducer

Warnings

Allergy alert:

  • Do not use if you are allergic to esomeprazole
  • Esomeprazole may cause severe reactions. Symptoms may include:
    • Skin reddening
    • blisters
    • rash

If an allergic reaction occurs, stop use and seek medical help right away.

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 tablet 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.
Package Label (Package label)
RITE AID Acid Reducer
Other Information (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)
Inactive Ingredients (Inactive ingredients)

black iron oxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid - ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono-and di-glycerides, polyethylene glycol, polysorbate 80, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulfate, sodium stearyl fumarate, sugar spheres (corn starch and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Do Not Use If You Have: (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.

Principal Display Panel

†Compare to the active ingredient in Nexium® 24R

SEE NEW WARNING INFORMATION

TREAT FREQUENT HEARTBURN

ESOMEPRAZOLE MAGNESIUM

Delayed-Release Tablets 20 mg*

Acid Reducer

TABLETS

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Nexium® 24HR.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP BROKEN OR MISSING.

KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

RITE AID

200 NEWBERRY COMMONS

ETTERS, PA 17319

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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Esomeprazole 20 mg

(*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP 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.




Advanced Ingredient Data


Raw Label Data

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