basic care esomeprazole magnesium

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Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

Allergy alert:

• Do not use if you are allergic to esomeprazole.
• Esomeprazole may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

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

Do not use if you have:

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 1, FD&C red no. 3, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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basic care

Capsules

Compare to Nexium^® 24 HR active ingredient

Esomeprazole Magnesium

Delayed-Release Capsules, 20 mg

Acid Reducer

Treats Frequent Heartburn

May Take 1 to 4 Days for Full Effect

24 HR

See New Warning Information

actual size

14 CAPSULES

One 14-day Course of Treatment

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

• basic care esomeprazole magnesium
• Esomeprazole
• FD&C BLUE NO. 1
• FD&C RED NO. 3
• FERRIC OXIDE RED
• GELATIN, UNSPECIFIED
• GLYCERYL MONOSTEARATE
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MEGLUMINE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POLYSORBATE 80
• SHELLAC
• SODIUM LAURYL SULFATE
• TALC
• TITANIUM DIOXIDE
• TRIETHYL CITRATE
• METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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Orange Book application contexts page 1 of 1 · 1 matching rows.

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Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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