Omeprazole and Sodium Bicarbonate

40mg / 1.1g

Product Details

Product Name:
Omeprazole and Sodium Bicarbonate
Strength:
40mg / 1.1g
Count:
30
NDC:
42291-585-30
Class:
Rx
Brand Name(s):
Zegerid, Zegerid OTC
Imprint Code:
SG;364
Color(s):
BLUE (Opaque White)
Shape:
CAPSULE
Score:
no score
Case Count:
72
Inactive Ingredients:
croscarmellose sodium and sodium stearyl fumarate. The capsules consist of gelatin and titanium dioxide. In addition the 40 mg/1100 mg capsule shell contains FD&C Blue 1. The capsules are printed with edible ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac and strong ammonia solution.
Indications and Usage:

1.1 Duodenal Ulcer
Omeprazole and sodium bicarbonate is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

1.2 Gastric Ulcer
Omeprazole and sodium bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer.

1.3 Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
Omeprazole and sodium bicarbonate is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.

Erosive Esophagitis
Omeprazole and sodium bicarbonate is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.

The efficacy of omeprazole and sodium bicarbonate used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), an additional 4-8 week courses of omeprazole and sodium bicarbonate may be considered.

1.4 Maintenance of Healing of Erosive Esophagitis
Omeprazole and sodium bicarbonate is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months.

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