Label: OMEPRAZOLE tablet, delayed release
-
Contains inactivated NDC Code(s)
NDC Code(s): 54868-5911-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 64861-303
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 27, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Omeprazole Delayed Release Tablets, 20 mg Drug Facts
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warning
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. 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.
- heartburn with lightheadedness, sweating or dizziness
- chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
Ask a doctor or pharmacist before use if you are taking
- clopidogrel bisulfate (anti-blood clotting medicine)
- warfarin (blood-thinning medicine)
- prescription antifungal or anti-yeast medicines
- diazepam (anxiety medicine)
- digoxin (heart medicine)
- tacrolimus (immune system medicine)
- atazanavir (medicine for HIV infection)
-
SPL UNCLASSIFIED SECTION
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
- it may take 1 to 4 days for full effect, although 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 chew or crush the tablets
- do not crush tablets in food
- do not use for more than 14 days unless directed by your doctor
- 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
- SPL UNCLASSIFIED SECTION
-
INACTIVE INGREDIENT
Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate
- QUESTIONS
-
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 Omeperazole 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 a 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.
Safety Record
For years, doctors have prescribed omeprazole to treat acid-related conditions in millions of people safely.
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.
- 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.
14-Day Course of Treatment
- 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 chew or crush the tablets.
- Do not crush tablets in food.
- Do not use for more than 14 days unless directed by your doctor.
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 trouble or pain swallowing food, vomiting with blood, or bloody or black stools. 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
- 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
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- clopidogrel bisulfate (anti-blood clotting medicine)
- warfarin (blood-thinning medicine)
- prescription antifungal or anti-yeast medicines
- diazepam (anxiety medicine)
- digoxin (heart medicine)
- tacrolimus (immune system medicine)
- atazanavir (medicine for HIV infection)
- 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
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
- Do not lie flat or bend over soon after eating.
- Do not eat late at night or just before bedtime.
- Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables.
- Eat slowly and do not eat big meals.
- If you are overweight, lose weight.
- If you smoke, quit smoking.
- Raise the head of your bed.
- Wear loose-fitting clothing around your stomach.
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 the 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 1-800-719-9260
Made in Israel
Manufactured by:
DEXCEL® LTD.
Southern Industrial Zone
Or Akiva 30600, Israel
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5911(NDC:64861-303) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE (UNII: 3NXW29V3WO) Hypromellose Acetate Succinate 12070923 (3 MM2/S) (UNII: 36BGF0E889) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) ETHANOLAMINE (UNII: 5KV86114PT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color brown (BROWNISH) Score no score Shape OVAL (capsule-shaped) Size 13mm Flavor Imprint Code 20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5911-0 6 in 1 CARTON 1 7 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022032 06/19/2008 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel