Ondansetron Ondansetron 4 MG Oral Tablet
1 INDICATIONS AND USAGE Ondansetron is 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 is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron is 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 )
Glenmark Generics Inc., USA
OVAL WHITE G1 4
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16 HOW SUPPLIED/STORAGE AND HANDLING
ONDANSETRON Tablets, USP • 4 mg (
ONDANSETRON hydrochloride, USP (dihydrate) equivalent to 4 mg of
ONDANSETRON), are white, oval, standard convex, film-coated tablets with ‘4’ on one side and ‘G1’ logo on the other side in: Bottles of 30 tablets (NDC 68462-105-30). Carton of 3 tablets (contains 1 card of 3 unit-of-use blisters) NDC 68462-105-33. 8 mg (
ONDANSETRON hydrochloride, USP (dihydrate) equivalent to 8 mg of
ONDANSETRON), are yellow, oval, standard convex, film-coated tablets with ‘8’ on one side and ‘G1’ logo on the other side in: Bottles of 30 tablets (NDC 68462-106-30). Carton of 3 tablets (contains 1 card of 3 unit-of-use blisters) NDC 68462-106-33 Bottles: Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP. Cartons: Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from light. Store blister in carton.
ONDANSETRON Orally Disintegrating Tablets, USP • 4 mg (as 4 mg
ONDANSETRON base) are white, circular, flat faced, uncoated tablets with ‘G’ engraved on one side and ‘4’ on the other side in: Carton of 30 tablets (contains 3 cards of 10 unit-of-use blisters) NDC 68462-157-13 • 8 mg (as 8 mg
ONDANSETRON base) are white, circular, flat faced, uncoated tablets with ‘G’ engraved on one side and ‘8’ on the other side in: Carton of 10 tablets (contains 1 card of 10 unit-of-use blisters) NDC 68462-158-11 Carton of 30 tablets (contains 3 cards of 10 unit-of-use blisters) NDC 68462-158-13 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
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