FDA Label for Omeprazole
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(IN EACH TABLET)
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- ASK A DOCOTOR BEFOR USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE 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 OF MANAGING HEARTBURN
- PATIENT PACKAGE INSERT
- PRINCIPAL DISPLAY PANEL - FOIL
- PRINCIPAL DISPLAY PANEL - BLISTER CARTON
- PRINCIPAL DISPLAY PANEL - LABEL
- PRINCIPAL DISPLAY PANEL - BOTTLE CARTON
Omeprazole Product Label
The following document was submitted to the FDA by the labeler of this product Sun Pharmaceutical Industries, 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 20 mg
Purpose
Acid reducer
Use
- 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 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 Docotor Befor 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:
- warfarin, clopidogrel or cilostazol (blood-thinning medicines)
- 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 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 Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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 complete relief of symptoms within 24 hours
- swallow 1 tablet with a glass of water before 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.
- 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.
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
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
anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate.
The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.
Questions Or Comments?
Call toll free 1-800-818-4555 weekdays.
Tips Of 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
Patient Package Insert
Omeprazole Delayed-Release Tablets, 20 mg
Acid Reducer
Please read all of this package insert before taking omeprazole delayed-release tablets 20 mg. Save this to read, as you need.
How Omeprazole Delayed-Release Tablets 20 mg Work For Your Frequent Heartburn
Omeprazole delayed-release tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers. Omeprazole delayed-release tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid. Omeprazole delayed-release tablets 20 mg are to be used once-a-day (every 24 hours), every day for 14 days.
What to Expect When Using Omeprazole Delayed-Release Tablets 20 mg
Omeprazole delayed-release tablets 20 mg are different type of medicine from antacids and other acid reducers. Omeprazole delayed-release tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours. Make sure you take the entire 14 days of dosing to treat your frequent heartburn.
Who Should Take Omeprazole Delayed-Release Tablets 20 mg
This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week.
- Children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
- Omeprazole delayed-release tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief or heartburn.
- Swallow 1 tablet with a glass of water before 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.
- 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
- 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
- warfarin, clopidogrel or cilostazol (blood-thinning medicines)
- 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)
- 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
- 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
How to Take Omeprazole Delayed-Release Tablets 20 mg
14-Day Course of Treatment
It is important not to chew or crush these tablets, or crush the tablets in food. This decreases how well omeprazole delayed-release tablets 20 mg work.
When to Take Omeprazole Delayed-Release Tablets 20 mg Again
You may repeat a 14-day course of therapy every 4 months.
When to Talk to Your Doctor
Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.
Warnings and When to Ask Your Doctor
Allergy alert: Do not use if you are allergic to omeprazole
Do not use if you have:
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have:
Ask a doctor or pharmacist before use if you are taking:
Stop use and ask a doctor if:
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. (1-800-222-1222)
Tips for Managing Heartburn
How are Omeprazole Delayed-Release Tablets 20 mg Sold
Omeprazole delayed-release tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.
For Questions or Comments About Omeprazole Delayed-Release Tablets 20 mg.
Call toll free 1-800-818-4555 weekdays.
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
Manufactured by:
Sun Pharmaceutical Industries Limited
Survey No. 259/15,
Dadra-396 191, (U.T. of D & NH), India.
PGPI0296
ISS. 07/2018
Principal Display Panel - Foil
62756-377-40
Omeprazole Delayed-release Tablet
20 mg
Acid reducer
PUSH THROUGH
Mfg. by: Sun Pharmaceutical Ind Ltd., India.
Dist. by: Sun Pharmaceutical Ind Inc., NJ 08512
Principal Display Panel - Blister Carton
NDC 62756-377-79
Treats Frequent Heartburn!
Occurring 2 Or More Days a Week
Compare to Prilosec OTC ® *
Omeprazole Delayed-release Tablets
20 mg
Acid Reducer
SWALLOW - DO NOT CHEW
28 (2 x 14) Unit-Dose Tablets
TWO 14-DAY COURSES OF TREATMENT
Principal Display Panel - Label
NDC 62756-377-21
Treats Frequent Heartburn! Occurring 2 Or More Days a Week
Omeprazole Delayed-release Tablets
20 mg
Acid Reducer
14 Tablets
ONE 14-DAY COURSE OF TREATMENT
Principal Display Panel - Bottle Carton
NDC 62756-377-12
Treats Frequent Heartburn!
Occurring 2 Or More Days a Week
Compare to Prilosec OTC ® *
Omeprazole Delayed-release Tablets
20 mg
Acid Reducer
SWALLOW - DO NOT CHEW
28 Tablets
2 BOTTLES INSIDE
TWO14-DAY COURSES OF TREATMENT
* Please review the disclaimer below.