Curist Heartburn Relief (Esomeprazole)
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each capsule)
*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)
Purpose
Acid reducer
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
OTC - DO NOT USE SECTION
Do not use if you have:
These may be signs of a serious condition. See your doctor.
- 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
OTC - ASK DOCTOR SECTION
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 doctor orpharmacist before use if you are
- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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).
Directions
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
- 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
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.
- 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.
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.
Questions
Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.
SPL UNCLASSIFIED SECTION
Distributed by:
Little Pharma Inc.
New York, NY 10023
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Curist
Heartburn Relief
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg*
Acid Reducer
24 HR; Treats Frequent Heartburn
42 CAPSULES
Three 14-day courses of treatment
May take 1 to 4 days for full effect