DILANTIN-125 Oral suspension Ref.[10566] Active ingredients: Phenytoin

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

DILANTIN (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula:

Each 5 mL of the oral suspension contains 125 mg of phenytoin, USP; alcohol, USP (maximum content not greater than 0.6 percent); banana flavor; carboxymethylcellulose sodium, USP; citric acid, anhydrous, USP; glycerin, USP; magnesium aluminum silicate, NF; orange oil concentrate; polysorbate 40, NF; purified water, USP; sodium benzoate, NF; sucrose, NF; vanillin, NF; and FD&C yellow No. 6.

Dosage Forms and Strengths

DILANTIN-125 is available as a 125 mg phenytoin/5 mL oral suspension of orange color with an orange-vanilla flavor.

How Supplied

DILANTIN-125 Oral Suspension is supplied as follows:

Package Configuration Strength NDC
8 oz glass bottles 125 mg phenytoin/5 mL 0071-2214-20
8 oz amber polyethylene terephthalate (PET) bottles 125 mg phenytoin/5 mL 0071-2214-35

DILANTIN-125 Suspension (phenytoin oral suspension, USP), 125 mg phenytoin/5 mL contains a maximum alcohol content not greater than 0.6 percent in an orange suspension with an orange-vanilla flavor.

Drugs

Drug Countries
DILANTIN Australia, Canada, France, Hong Kong, Israel, New Zealand, Singapore, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.