Donepezil Hydrochloride Tablets USP 5mg
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Donepezil Hydrochloride Tablets USP 5mg Technical Specification:

Product Name: Donepezil Hydrochloride Tablets USP 5mg
Brand Name: Generics
Strength: (5mg), (10mg)
Dosage Form: Tablets (Film-coated)
Route of Administration: Via oral Route
Packing: 30s, 90s, 100s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anti-Alzheimer’s
Indication: Donepezil hydrochloride tablets USP are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.
Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Donepezil Hydrochloride Tablets USP 5mg
    Each Film-coated tablet contains:
    Donepezil Hydrochloride USP……………………………5mg
    Excipients…………………………………………………….…. q.s.
    Colurs: Titanium Dioxide
  • Donepezil Hydrochloride Tablets USP 10mg
    Each Film-coated tablet contains:
    Donepezil Hydrochloride USP……………………………10mg
    Excipients…………………………………………………….…. q.s.
    Colurs: Sunset yellow and Titanium Dioxide

THERAPEUTIC INDICATIONS:

Donepezil hydrochloride tablets USP are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.

Keep medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:  Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Donepezil Hydrochloride Tablets USP 5mg
B. Donepezil Hydrochloride Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Donepezil Hydrochloride Tablets USP 5mg
Each Film coated tablet contains:
Donepezil Hydrochloride USP……………………………5mg
Excipients…………………………………………………….…. q.s.
Colurs: Titanium Dioxide

b) Donepezil Hydrochloride Tablets USP 10mg
Each Film coated tablet contains:
Donepezil Hydrochloride USP……………………………10mg
Excipients…………………………………………………….…. q.s.
Colurs: Sunset yellow and Titanium Dioxide

THERAPEUTIC INDICATIONS:

Donepezil hydrochloride tablets USP are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

Dosage: As directed by the Physician.