Drug Facts

Active ingredient

(in each capsule)

Purpose

Esomeprazole 20 mg

Acid reducer

(*Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium 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 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

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 the reach of children.

In case of overdose, get medical help or contact a Poison Control Center 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 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° to 25°C (68° to 77°F)
Tamper Evident: Do not use if printed safety seal under cap or band around the center of each capsule is broken or missing.

Inactive ingredients

gelatin, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion type C, mono-and di-glycerides, polysorbate 80, sugar sphere (contains- sucrose, corn starch and purified water), sodium lauryl sulphate, talc, triethyl citrate and titanium dioxide.

Each capsule is imprinted with blue pharmaceutical ink which contains butyl alcohol, dehydrated alcohol, FD & C Blue # 2 aluminum lake, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and having one circular line which contains FD & C Blue No. 2 aluminum lake, gelatin and polysorbate 80.

Questions or comments?

Call toll-free 1-877-835-5472

Mon – Fri 9AM – 5PM EST.

Made in India
For most recent product information, visit www.amneal.com

Principal Display Panel

NDC 69238-1050-4

Esomeprazole Magnesium Delayed-Release Capsules, USP/Acid Reducer (OTC)

20 mg

14 Capsules (Container Label)

Amneal Pharmaceuticals LLC

NDC 69238-1050-3

Esomeprazole Magnesium Delayed-Release Capsules, USP /Acid Reducer (OTC)