GENERIC NAME OF THE MEDICINAL PRODUCT:
2. Guanfacine Tablets USP 2mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains:
Guanfacine Hydrochloride USP
Equivalent to Guanfacine………1mg
Excipients………………………………q.s
Color: Sunset yellow FCF
2. Guanfacine Tablets USP 2mg
Each tablet contains:
Guanfacine Hydrochloride USP
Equivalent to Guanfacine…………2mg
Excipients………………………………….q.s
Color: Tartrazine yellow
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Guanfacine Tablets USP 1mg Technical Specification:
| Product Name: | Guanfacine Tablets USP |
| Brand Name: | Generic |
| Strength: | (1mg), (2mg) |
| Dosage Form: | Tablets |
| 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, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antihypertensive |
| Indication: | Guanfacine is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Guanfacine Tablets USP 1mg
2. Guanfacine Tablets USP 2mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Guanfacine Tablets USP 1mg
Each tablet contains:
Guanfacine Hydrochloride USP
Equivalent to Guanfacine………1mg
Excipients………………………………q.s
Color: Sunset yellow FCF
2. Guanfacine Tablets USP 2mg
Each tablet contains:
Guanfacine Hydrochloride USP
Equivalent to Guanfacine…………2mg
Excipients………………………………….q.s
Color: Tartrazine yellow
THERAPEUTIC INDICATIONS:
Guanfacine is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
