OMEPRAZOLE AND SODIUM BICARBONATE- omeprazole and sodium bicarbonate capsule
Zydus Lifesciences Limited
----------
Omeprazole, USP ……………………………………….20 mg
Sodium Bicarbonate, USP …………………………....1100 mg
Omeprazole, USP .............................................................................Acid reducer
Sodium Bicarbonate, USP ………Allows absorption of this omeprazole product
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Repeated 14 Day Courses (if needed)
• children under 18 years of age: ask a doctor.
Heartburn in children may sometimes be caused by a serious condition.
croscarmellose sodium, FD&C blue # 1, gelatin, magnesium stearate, polysorbate 80, sodium lauryl sulfate and titanium dioxide. The capsule shell is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.
Serious side effects associated with use of this drug product may be reported to this number: 1-877-993-8779 or visit www.zydususa.com
Hours of operation:
9:00 am to 5:00 pm
EST M-F.
You may report side effects to FDA at 1-800-FDA-1088.
How Omeprazole and Sodium Bicarbonate Capsule Works For Your Frequent Heartburn
Omeprazole and sodium bicarbonate capsule works differently from other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and sodium bicarbonate capsule stops acid production at the source – the acid pump that produces stomach acid. Omeprazole and sodium bicarbonate capsule is to be used once a day (every 24 hours), every day for 14 days.
What to Expect When Using Omeprazole and Sodium Bicarbonate Capsule
Omeprazole and sodium bicarbonate capsule is a different type of medicine from antacids and other acid reducers. Omeprazole and sodium bicarbonate capsule 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.
Tips for Managing Heartburn
How are Omeprazole and Sodium Bicarbonate Capsules Sold
Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg are white to off-white fine powder filled in hard gelatin capsule shells of size '00' having an opaque white cap and an opaque white body printed with '503' on body in black ink and a blue tamper evident band and are available as follows:
NDC 68382-503-67 in one HDPE bottle of 14 capsules
NDC 68382-503-17 in two HDPE bottles of 28 capsules (one bottle contains 14 capsules)
NDC 68382-503-04 in three HDPE bottles of 42 capsules (one bottle contains 14 capsules)
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.
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole and sodium bicarbonate capsule |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
Labeler - Zydus Lifesciences Limited (918596198) |
Registrant - Zydus Lifesciences Limited (918596198) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Zydus Lifesciences Limited | 918596198 | ANALYSIS(70771-1337) , MANUFACTURE(70771-1337) |