Label: OMEPRAZOLE AND SODIUM BICARBONATE capsule
- NDC Code(s): 13107-117-14, 13107-117-28, 13107-117-42
- Packager: Aurolife Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated September 11, 2019
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- Active ingredient(s)
- Do not use if you have:
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 diziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulder; or lightheadedness
- frequent chest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- a sodium-restricted diet
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 medicine)
- prescription antiretrovirals (medicines for HIV infection)
- Methotrexate (arthiritis medicine)
- any other prescription drugs, Sodium bicarbonate may interact with certain prescription drugs.
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- 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 one 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 ofen than every 4 months unless directed by a doctor
- children under 18 years of age; ask a doctor. Heartburn in children may sometines be caused by a serious condition.
- each capsule contains: sodium 303 mg
- read the direction, warnings and accompanying label information before use
- store at 20° to 25°C (68° to 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 is missing, open or broken.
- keep product out of high heat and humidity
- prtect product from moisture
- Inactive Ingredients
- Questions or Comments?
How Omeprazole and Sodium Bicarbonate Capsules Work For Your Frequent Heartburn
Omeprazole and sodium bcarbonate capsules work differently form other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and sodium bicarbonate capsules stop acid production at the source-the acid pump that produces stomach acid. Omeprazole and sodium bicarbonate capsules are to be used once a day (every 24 hours), every day for 14 days.
What to Expect When Using Omeprazole and Sodium Bicarbonate Capsules
Omeprazole and sodium bicarbonate capsules is a different type of medicine from antacids and other acid reducers. Omeprazole and sodium bicarbonate capsules 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
- 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 likelhy 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.
How are Omeprazole and Sodium Bicarbonate Capsules Sold
Omeprazole and sodium bicarbonate capsules are availble in 14, 28 and 42 count sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use of 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.
- PRINCIPAL DISPLAY PANEL - 14 Capsule Carton
- PRINCIPAL DISPLAY PANEL - 28 Capsule Carton
PRINCIPAL DISPLAY PANEL - 42 Capsule Carton
* Compare to Zegerid OTC® Capsules NDC 13107-117-42
Treats Frequent Heartburn
Omeprazole and Sodium Bicarbonate Capsules
- Omeprazole 20 mg / Acid Reducer
- Sodium Bicarbonate 1100 mg / Allows Absorption of this Omperazole Product
Three 14-Day Course of Treatment
INGREDIENTS AND APPEARANCE
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole and sodium bicarbonate capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13107-117 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) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1100 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: MB5IUD6JUA) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (Light Blue Opaque Cap) , WHITE (White Opaque Body) Score no score Shape CAPSULE (Capsule) Size 24mm Flavor Imprint Code U;96 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13107-117-14 1 in 1 CARTON 09/30/2014 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:13107-117-28 2 in 1 CARTON 09/30/2014 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:13107-117-42 3 in 1 CARTON 09/30/2014 3 14 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 ANDA204923 09/30/2014 Labeler - Aurolife Pharma, LLC (829084461) Establishment Name Address ID/FEI Business Operations Aurolife Pharma, LLC 829084461 MANUFACTURE(13107-117) Establishment Name Address ID/FEI Business Operations Aurolife Pharma LLC 078296263 RELABEL(13107-117) , REPACK(13107-117) , LABEL(13107-117) , PACK(13107-117)