Label: GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE- omeprazole, sodium bicarbonate capsule, gelatin coated
- NDC Code(s): 0113-0058-03
- Packager: L. Perrigo Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 16, 2020
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- Official Label (Printer Friendly)
- Active ingredients (in each capsule)
- Purpose
- Use
- Warnings
- Do not use if you have:
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Ask a doctor before use if you have
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- had heartburn over 3 months. This may be a sign of a more serious condition.
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- heartburn with lightheadedness, sweating or dizziness
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- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
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- frequent chest pain
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- frequent wheezing, particularly with heartburn
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- unexplained weight loss
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- nausea or vomiting
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- stomach pain
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- a sodium-restricted diet
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Ask a doctor or pharmacist before use if you are taking
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- warfarin, clopidogrel or cilostazol (blood-thinning medicines)
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- prescription antifungal or anti-yeast medicines
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- diazepam (anxiety medicine)
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- digoxin (heart medicine)
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- tacrolimus or mycophenolate mofetil (immune system medicines)
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- prescription antiretrovirals (medicines for HIV infection)
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- methotrexate (arthritis medicine)
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- 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.
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Directions
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- for adults 18 years of age and older
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- this product is to be used once a day (every 24 hours), every day for 14 days
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- 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
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- swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
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- take every day for 14 days
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- do not take more than 1 capsule a day
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- do not chew or crush the capsule
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- do not open capsule and sprinkle on food
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- do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
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- you may repeat a 14-day course every 4 months
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- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
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- children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
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Other information
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- each capsule contains: sodium 303 mg
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- read the directions, warnings and accompanying label information before use
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- store at 20-25oC (68-77oF)
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- tamper-evident: do not use if the band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing.
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- keep product out of high heat and humidity
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- protect product from moisture
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole, sodium bicarbonate capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0058 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, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1100 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (blue band) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code 732 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0058-03 3 in 1 CARTON 06/19/2017 1 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 ANDA201361 06/19/2017 Labeler - L. Perrigo Company (006013346)