Ondansetron Hydrochloride 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)
Aurobindo Pharma Limited
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16 HOW SUPPLIED/STORAGE AND HANDLING Ondansetron Tablets USP, 4 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘F’ on one side and ‘91’ on the other side. Bottles of 30 NDC 65862-187-30 Bottles of 500 NDC 65862-187-05 Bottles of 1,000 NDC 65862-187-99 1 x 3 Unit-dose Tablets NDC 65862-187-03 10 x 10 Unit-dose Tablets NDC 65862-187-10 Ondansetron Tablets USP, 8 mg are yellow colored, oval shaped, film-coated tablets debossed with ‘F’ on one side and ‘92’ on the other side. Bottles of 30 NDC 65862-188-30 Bottles of 500 NDC 65862-188-05 Bottles of 1,000 NDC 65862-188-99 1 x 3 Unit-dose Tablets NDC 65862-188-03 10 x 10 Unit-dose Tablets NDC 65862-188-10 Ondansetron Tablets USP, 24 mg are pink colored, oval shaped, film-coated tablets debossed with ‘C’ on one side and ‘71’ on the other side. Unit-dose Packs of 1 Tablet NDC 65862-189-11 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.
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