GENERIC NAME OF THE MEDICINAL PRODUCT:

Methylphenidate HCl ER Tablet IP 5mg
Methylphenidate HCl ER Tablet IP 18mg
Methylphenidate HCl ER Tablet IP 27mg
Methylphenidate HCl ER Tablet IP 36mg
Methylphenidate HCl ER Tablet IP 54mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Methylphenidate HCl ER Tablet IP 5mg
Each film-coated tablet contains:
Methylphenidate HCl IP………………5mg
Colours: Titanium Dioxide

b) Methylphenidate HCl ER Tablet IP 18mg
Each film-coated tablet contains:
Methylphenidate HCl IP………………18mg
Colours: Titanium Dioxide Red

c) Methylphenidate HCl ER Tablet IP 27mg
Each film-coated tablet contains:
Methylphenidate HCl IP………………27mg
Colours: Quinoline Yellow

d) Methylphenidate HCl ER Tablet IP 36mg
Each film-coated tablet contains:
Methylphenidate HCl IP………………36mg
Colours: Indigo carmine

e) Methylphenidate HCl ER Tablet IP 54mg
Each film-coated tablet contains:
Methylphenidate HCl IP………………54mg
Colours: Orange 4


THERAPEUTIC INDICATIONS:

This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Methylphenidate belongs to a class of drugs known as stimulants.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.

Methylphenidate HCl ER Tablet 54mg Technical Specification:

Product Name:
Methylphenidate HCl ER Tablet IP
Brand Name: Generics
Strength: (5mg), (18mg), (27mg), (36mg), (54mg)
Dosage Form: Tablets (Un-Coated)
Route of Administration: Via oral Route
Packing: 30s, 90s, 100s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antipsychotic drug, Central Nervous System, central nervous system (CNS) stimulants.
Indication: This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Methylphenidate belongs to a class of drugs known as stimulants.
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Methylphenidate HCl ER Tablet IP 5mg
  • Methylphenidate HCl ER Tablet IP 18mg
  • Methylphenidate HCl ER Tablet IP 27mg
  • Methylphenidate HCl ER Tablet IP 36mg
  • Methylphenidate HCl ER Tablet IP 54mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • a) Methylphenidate HCl ER Tablet IP 5mg
    Each film-coated tablet contains:
    Methylphenidate HCl IP………………5mg
    Colours: Titanium Dioxide
  • b) Methylphenidate HCl ER Tablet IP 18mg
    Each film-coated tablet contains:
    Methylphenidate HCl IP………………18mg
    Colours: Titanium Dioxide Red
  • c) Methylphenidate HCl ER Tablet IP 27mg
    Each film-coated tablet contains:
    Methylphenidate HCl IP………………27mg
    Colours: Quinoline Yellow
  • d) Methylphenidate HCl ER Tablet IP 36mg
    Each film-coated tablet contains:
    Methylphenidate HCl IP………………36mg
    Colours: Indigo carmine
  • e) Methylphenidate HCl ER Tablet IP 54mg
    Each film-coated tablet contains:
    Methylphenidate HCl IP………………54mg
    Colours: Orange 4

THERAPEUTIC INDICATIONS:

  • This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Methylphenidate belongs to a class of drugs known as stimulants.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

  • Storage:  Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
  • Dosage:  As directed by the Physician.