NDC | 11523-7276-1, 11523-7276-2 |
Set ID | 5ad1ca2b-3119-b8c2-e053-2a91aa0a2f77 |
Category | HUMAN OTC DRUG LABEL |
Packager | Bayer HealthCare LLC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA201361 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
-
ASK 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
● a sodium-restricted diet
-
ASK DOCTOR/PHARMACIST
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)
● any other prescription drugs. Sodium bicarbonate may interact
with certain prescription drugs.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
Directions
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, although some people
get complete relief of symptoms within 24 hours
14-Day Course of Treatment
● swallow 1 capsule with a glass of water at least 1 hour
before eating in the morning
● take every day for 14 days
● do not take more than 1 capsule a day
● do not chew or crush the capsule
● do not open capsule and sprinkle on food
● 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.
Heartburn in children may sometimes be caused by a
serious condition.
-
Other information
Other information
● each tablet contains: sodium 303 mg
● read the directions, warnings and accompanying label
information before use
● store at 20°-25°C (68°-77°F)
● tamper-evident: do not use if the blue band around the
capsule is missing or broken. Do not use if foil inner seal
imprinted with “Sealed for your protection” is missing, open or
broken.
● keep product out of high heat and humidity
● protect product from moisture
- INACTIVE INGREDIENT
- Questions or comments
- 42 count carton
-
INGREDIENTS AND APPEARANCE
ZEGERID OTC
omeprazole and sodium bicarbonate capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7276 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 1100 mg Inactive Ingredients Ingredient Name Strength SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (blue band) Score no score Shape OVAL Size 23mm Flavor Imprint Code ZEG Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-7276-1 1 in 1 CARTON 10/01/2017 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:11523-7276-2 1 in 1 CARTON 10/01/2017 2 42 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201361 10/01/2017 Labeler - Bayer HealthCare LLC. (112117283)