GENERIC NAME OF THE MEDICINAL PRODUCT:
2. Tizanidine Tablets USP 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Tizanidine Hydrochloride USP 2.288mg
Equivalent to Tizanidine………….. 2mg
Excipients…………………………………q.s
Color: Sunset yellow FCF
2. Tizanidine Tablets USP 4mg
Each uncoated tablet contains:
Tizanidine Hydrochloride USP 4.576mg
Equivalent to Tizanidine……………4mg
Excipients………………………………….q.s
Color: Cochineal
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
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:
Store in dry place.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Tizanidine Tablets USP 2mg Technical Specification:
| Product Name: | Tizanidine Tablets USP |
| Brand Name: | Generic |
| Strength: | (2mg), (4mg) |
| Dosage Form: | Tablets (Uncoated) |
| 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: | Analgesic, Muscle Relaxant |
| Indication: | Tizanidine is used to help relax certain muscles in your body. It relieves spasms, cramping, and tightness of the muscles caused by medical problems, such as multiple sclerosis or certain injuries to the spine. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Tizanidine Tablets USP 2mg
2. Tizanidine Tablets USP 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Tizanidine Tablets USP 2mg
Each uncoated tablet contains:
Tizanidine Hydrochloride USP 2.288mg
Equivalent to Tizanidine…………………..2mg
Excipients………………………………………..q.s
Color: Sunset yellow FCF
2. Tizanidine Tablets USP 4mg
Each uncoated tablet contains:
Tizanidine Hydrochloride USP 4.576mg
Equivalent to Tizanidine……………….4mg
Excipients…………………………………..q.s
Color: Cochineal
THERAPEUTIC INDICATIONS:
Tizanidine is used to help relax certain muscles in your body. It relieves spasms, cramping, and tightness of the muscles caused by medical problems, such as multiple sclerosis or certain injuries to the spine.
CAUTION & WARNING:
CAUTION: Read the enclosed leaflet before use.
Keep the 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: Store at 20° to 25°C (68° to 77°F).
Store in a dry place.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
