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Ondansetron 4 MG Oral Tablet

1 INDICATIONS AND USAGE Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: • highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . • initial and repeat courses of moderately emetogenic cancer chemotherapy. • radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are a 5-HT 3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . ( 1 ) • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. ( 1 ) • nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. ( 1 ) • postoperative nausea and/or vomiting. ( 1 )

Mylan Pharmaceuticals Inc.


4 months ago ROUND WHITE M 315 Ondansetron 4 MG Oral Tablet

ROUND WHITE M 315

4 months ago ROUND WHITE M 315 Ondansetron 4 MG Oral Tablet

M 315 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING Ondansetron Tablets, USP are available containing ondansetron hydrochloride, USP equivalent to 4 mg or 8 mg of ondansetron. The 4 mg tablets are white, film-coated, round, unscored tablets debossed with 315 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0315-93 bottles of 30 tablets The 8 mg tablets are orange, film-coated, round, unscored tablets debossed with 344 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0344-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.


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