FDA Label for Omeprazole
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USE
- ALLERGY ALERT
- DO NOT USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU HAVE:
- ASK A DOCTOR OR PHARMACIST BEOFRE USING IF YOU ARE
- STOP USE AND ASK A DOCTOR IF:
- IF PREGNANT OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- TIPS FOR MANAGING HEARTBURN
- CARTON LABEL
- BOTTLE LABEL
Omeprazole Product Label
The following document was submitted to the FDA by the labeler of this product Thirty Madison Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Omeprazole USP, 20mg
Purpose
Acid Reducer
Use
• Treats frequent heartburn (occurs2 or more days a week)
• not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Allergy Alert
Do not use if you are allergic to Omeprazole
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 Beofre Using If You Are
taking:
• warfarin, clopidogrel or cilostazol (blood thinning medications)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)
• tacrolimus or mycophenolate mofetil (immune system medicines)
• prescription antiretrovirals (medicines for HIV infection)
• methotrexate (arthritis medicine)
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 treatement 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 Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222)
Directions
• for adults 18 years of age and older
•this product is to be used once a day (every 24 hours), every day for 14 days
•it may take 1 to 4 days for full effect, some people get relief of symptoms within 24 hours
• 14 day course of treatment
•swallow 1 tablet with a glass of water befre eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets
• Repeated 14 days 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. 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) and protect from moisture
Inactive Ingredients
ammonia solution, ammonium hydroxide, carnauba wax, hypromellose acetate succinate, hypromellose, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, sodium stearate, sodium starch glycolate, shellac glaze, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanim dioxide, triethyl citrate, yellow iron oxide
Questions Or Comments?
call 1-888-375-3784
Tips For Managing Heartburn
• Do not lie flat or bend over after eating
• Do not wear tight-fitting clothing around the stomach
• Do not eat before bedtime
• Raise the head of your bed
• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
• Eat slowly and avoid big meals
• If overweight, lose weight
• Quit smoking
Carton Label
Bottle Label
* Please review the disclaimer below.