GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Divalporex Sodium Tablets USP 750mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Divalporex Sodium Tablets USP 750mg
Each film coated tablet contains:
Divalporex Sodium USP
Equivalent to valproic acid……………750mg
Excipients……………………………………..q.s.
Colour: Ferric Oxide Red USP-NF

THERAPEUTIC INDICATIONS:

Divalproex sodium is indicated for the treatment of the manic episodes associated with bipolar disorder, to treat seizure disorder and to prevent migraine headache. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

CAUTION & SCHEDULE:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SCHEDULE H: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled room Temperature]. Dispense in a USP tight, light-resistant container
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Divalporex Sodium Tablets USP 750mg Technical Specification:

Product Name:Divalporex Sodium Tablets USP
Brand Name:Generic
Strength:750mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Anti Epileptic
Indication: Divalproex sodium is indicated for the treatment of the manic episodes associated with bipolar disorder, to treat seizure disorder and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.
Storage:Store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled room Temperature]

 GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Divalporex Sodium Tablets USP 750mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Divalporex Sodium Tablets USP 750mg
    Each film-coated tablet contains:
    Divalporex Sodium USP
    Equivalent to valproic acid……………750mg
    Excipients……………………………………..q.s.
    Colour: Yellow oxide of iron

THERAPEUTIC INDICATIONS

Divalproex sodium is indicated for the treatment of the manic episodes associated with bipolar disorder, to treat seizure disorder and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

CAUTION & SCHEDULE:

CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SCHEDULE H : To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Dispense in a USP tight, light-resistant container
Dosage:  As directed by the Physician