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PHENYTOIN SODIUM ER 100 100 CAP - 100 mg/1 CAPSULE, EXTENDED RELEASE
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PHENYTOIN SODIUM ER 100 100 CAP

Generic: Phenytoin Sodium

PHENYTOIN SODIUM ER 100 100 CAP

NDC:57664-0808-88
Manufacturer:Sun Pharmaceutical Industries, Inc.
Strength:100 mg/1
Dosage Form:CAPSULE, EXTENDED RELEASE
Route:ORAL

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Drug Information

Identification

Generic Name

Phenytoin Sodium

Brand Name

Phenytoin Sodium

Labeler / Distributor

Sun Pharmaceutical Industries, Inc.

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

CAPSULE, EXTENDED RELEASE

Route of Administration

ORAL

FDA Application Number

ANDA040684

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

Pharmacological Class

Anti-epileptic AgentCytochrome P450 1A2 Inducers [MoA]Cytochrome P450 2B6 Inducers [MoA]Cytochrome P450 2C19 Inducers [MoA]Cytochrome P450 2C8 Inducers [MoA]Cytochrome P450 2C9 Inducers [MoA]Cytochrome P450 2D6 Inducers [MoA]Cytochrome P450 3A Inducers [MoA]Decreased Central Nervous System Disorganized Electrical Activity [PE]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documentsDSCSA compliance resource hub

Drug Resources

Phenytoin sodium Drug PageNDC 57664-0808-88 Lookup

Clinical Drug Information

Indications & Usage

Use for relief of occasional sleeplessness caused by stress and repetitive thoughts

Warnings

Warnings When using this product keep away from eyes Stop use and ask a doctor if sleeplessness persists for more than two weeks: insomnia can be a symptom of serious underlying medical illness If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions adults: apply 2 sprays onto the tongue. Additional sprays may be taken during the night as needed. children under 12: ask a doctor

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.