FDA Label for Omeprazole
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(IN EACH CAPSULE)
- PURPOSE
- USE
- WARNINGS
- 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,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
Omeprazole Product Label
The following document was submitted to the FDA by the labeler of this product Ohm Laboratories 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 Capsule)
Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium, USP)
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 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:
• 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 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• do not use for more than 14 days unless directed by your doctor• swallow whole. Do not chew or crush capsules.• 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
Other Information
• read the directions and warnings before use.• keep the carton. It contains important information.• Store at 20-25°C (68-77°F). [See USP controlled room temperature]. Protect from moisture
Inactive Ingredients
FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate
Questions?
call 1-800-406-7984
TAMPER-EVIDENT FEATURES: Do not use if foil seal under cap imprinted with 'sealed for your protection' or transparent band around center of capsule are missing, torn or broken.
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
Distributed by:
Ohm Laboratories Inc.,
14 Terminal Road, New Brunswick,
NJ 08901, USA
0618
Package/Label Principal Display Panel
NDC 51660-061-14
Treats FREQUENT Heartburn! 24 HR
Omeprazole Delayed-release Capsules
20 mg* / Acid Reducer
ohm®
14 CAPSULES
One 14-day course of treatment
May take 1 to 4 days for full effect
Principal Display Panel
NDC 51660-061-14
Treats FREQUENT Heartburn! 24 HR
Omeprazole Delayed-release Capsules
20 mg* / Acid Reducer
ohm®
14 CAPSULES
One 14-day course of treatment
May take 1 to 4 days for full effect
NDC 51660-061-27
2*14 COUNT BOTTLE INSIDE
Treats FREQUENT Heartburn! 24 HR
Omeprazole Delayed-release Capsules
20 mg* / Acid Reducer
ohm®
28 CAPSULES
Two 14-day courses of treatment
May take 1 to 4 days for full effect
NDC 51660-061-44
TRIPLE PACK
3*14 COUNT BOTTLE INSIDE
Treats FREQUENT Heartburn! 24 HR
Omeprazole Delayed-release Capsules
20 mg* / Acid Reducer
ohm®
42 CAPSULES
Three 14-day courses of treatment
May take 1 to 4 days for full effect
* Please review the disclaimer below.