Quality Choice Esomeprazole Magnesium Delayed Release Capsules 666
Esomeprazole Magnesium by
Drug Labeling and Warnings
Esomeprazole Magnesium by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release
Chain Drug Marketing Association Inc.
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Quality Choice Esomeprazole Magnesium Delayed Release Capsules 666
ACTIVE INGREDIENT(in each capsule)
*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)
USE(S)
- 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 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 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
KEEP OUT OF 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 20-25ºC (68-77ºF)
INACTIVE INGREDIENT SECTION
FD&C blue 1, FD&C red 3, FD&C red 40, ferroso ferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di-glycerides, polysorbate 80, potassium hydroxide, shellac, sodium lauryl sulfate, sugar spheres (contains corn starch, sucrose, water), talc, titanium dioxide, triethyl citrate.
OTHER SAFETY INFORMATION
Tips of Managing Heartburn
- Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
- Eat slowly and do not eat big meals.
- Do not eat late at night or just before bedtime.
- Do not lie flat or bend over soon after eating.
- Raise the head of your bed.
- Wear loose-fitting clothing around your stomach.
- If you are overweight, lose weight.
- If you smoke, quit smoking.
Do not use if seal under bottle cap imprinted with “SEALED FOR YOUR PROTECTION” or blue band around the center of each capsule is broken or missing.
KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.
PRINCIPAL DISPLAY PANEL
QC ® QUALITY CHOICE
NDC: 83324-010-14
*Compare to the Active Ingredient in Nexium®
Esomeprazole Magnesium
Acid Reducer
Delayed-Release Capsules USP, 20 mg*
See new warning information
Treats Frequent Heartburn
24 HR Capsules
May take 1 to 4 days for full effect
14 CAPSULES - One 14-day course of treatment
QC ® QUALITY CHOICE
NDC: 83324-010-42
*Compare to the Active Ingredient in Nexium®
Esomeprazole Magnesium
Acid Reducer
Delayed-Release Capsules USP, 20 mg*
See new warning information
Treats Frequent Heartburn
24 HR Capsules
May take 1 to 4 days for full effect
42 CAPSULES - One 14-day course of treatment
| ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed release |
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| Labeler - Chain Drug Marketing Association Inc. (011920774) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Guardian Drug Company | 119210276 | MANUFACTURE(83324-010) | |