Esomeprazole Magnesium (esomeprazole magnesium 20 mg) Dailymed

Warnings

Allergy alert:

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

• skin reddening
• bulers
• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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 1-8 77 - 835 - 5472

Mon – Fri 9AM – 5PM EST.

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

Otc - Purpose Section

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)

20 mg

42 Capsules (Carton Pack)

Amneal Pharmaceuticals LLC