GENERIC NAME OF THE MEDICINAL PRODUCT:
2. Methylphenidate Hydrochloride Extended-Release Tablets USP 18mg
3. Methylphenidate Hydrochloride Extended-Release Tablets USP 27mg
4. Methylphenidate Hydrochloride Extended-Release Tablets USP 36mg
5. Methylphenidate Hydrochloride Extended-Release Tablets USP 54mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….10mg
Excipients………………………………. q. s
Color: Sunset yellow FCF
2. Methylphenidate Hydrochloride Extended-Release Tablets USP 18mg
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….18mg
Excipients………………………………. q. s
Color: Sunset yellow
3. Methylphenidate Hydrochloride Extended-Release Tablets USP 27mg
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….27mg
Excipients……………………………….q.s
Color: Sunset yellow lake
4. Methylphenidate Hydrochloride Extended-Release Tablets USP 36mg
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….36mg
Excipients……………………………….q.s
Color: Ponceau 2R
5. Methylphenidate Hydrochloride Extended-Release Tablets USP 54mg
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….54mg
Excipients……………………………….q.s
Color: Ponceau 4R
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 protected from light and moisture.
DOSAGE: As directed by the Psychiatrists.
Attach dispensing label as per end country.
Methylphenidate Hydrochloride Extended-Release Tablets USP 18mg Technical Specification:
| Product Name: | Methylphenidate Hydrochloride Extended-Release Tablets USP |
| Brand Name: | Generic |
| Strength: | (10mg), (18mg), (27mg), (36mg), (54mg) |
| 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, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Central Nervous System Stimulants |
| Indication: | Methylphenidate is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy. |
| Storage: | Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Methylphenidate Hydrochloride Extended-Release Tablets USP 10mg
2. Methylphenidate Hydrochloride Extended-Release Tablets USP 18mg
3. Methylphenidate Hydrochloride Extended-Release Tablets USP 27mg
4. Methylphenidate Hydrochloride Extended-Release Tablets USP 36mg
5. Methylphenidate Hydrochloride Extended-Release Tablets USP 54mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Methylphenidate Hydrochloride Extended-Release Tablets USP 10mg
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….10mg
Excipients………………………………. q. s
Color: Sunset yellow FCF
2.Methylphenidate Hydrochloride Extended-Release Tablets USP 18mg
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….18mg
Excipients………………………………. q. s
Color: Sunset yellow
3. Methylphenidate Hydrochloride Extended-Release Tablets USP 27mg
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….27mg
Excipients……………………………….q.s
Color: Sunset yellow lake
4. Methylphenidate Hydrochloride Extended-Release Tablets USP 36mg
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….36mg
Excipients……………………………….q.s
Color: Ponceau 2R
5. Methylphenidate Hydrochloride Extended-Release Tablets USP 54mg
Each film-coated tablet contains:
Methylphenidate Hydrochloride USP
Equivalent to Methylphenidate …………….54mg
Excipients……………………………….q.s
Color: Ponceau 4R
THERAPEUTIC INDICATIONS:
Methylphenidate is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy.
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: Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.
Store in dry place protected from light and moisture.
DOSAGE: As directed by the Psychiatrists.
Attach dispensing label as per end country.
