RITALIN Tablet Ref.[10589] Active ingredients: Methylphenidate

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Ritalin contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration.

Ritalin-SR contains methylphenidate hydrochloride, a CNS stimulant. It is available as extended-release tablets of 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is:

Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol.

Ritalin tablets contains the following inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).

Ritalin-SR extended-release tablets contains the following inactive ingredients: cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein.

Dosage Forms and Strengths

Tablets

  • 5 mg, round, yellow, flat with CIBA monograpm on one side and NDC# 7 on the reverse side
  • 10 mg, round, pale green, biconvex with CIBA monograpm on one side and NDC# 3 and a partial bisection on the reverse side
  • 20 mg, round, pale yellow, biconvex with CIBA monograpm on one side and NDC# 34 and a partial bisection on the reverse side

Extended-release Tablets

  • 20 mg extended-release tablets, white to off-white, round, bicinvex, film coated with the ‘CIBA’ monograpm and ‘16’ on one side printed in black ink
How Supplied

Ritalin Tablets

5 mg tablets (NDC 0078-0439-05) round, yellow, (imprinted CIBA 7) supplied in bottles of 100

10 mg tablets (NDC 0078-0440-05) round, pale green, scored, (imprinted CIBA 3) supplied in bottles of 100

20 mg tablets (NDC 0078-0441-05) round, pale yellow, scored, (imprinted CIBA 34) supplied in bottles of 100

Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].

Protect from light.

Dispense in tight, light-resistant container (USP).

Ritalin-SR Extended-release Tablets

20 mg SR extended-release tablets (NDC 0078-0442-05), round, white, coated, (imprinted CIBA 16) supplied in bottles of 100

Protect from moisture.

Dispense in tight, light-resistant container (USP).

Disposal

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Ritalin and Ritalin-SR by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix Ritalin or Ritalin-SR with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and discard Ritalin or Ritalin-SR in the household trash.

Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936

Drugs

Drug Countries
RITALIN Austria, Australia, Canada, Germany, Hong Kong, Ireland, Israel, Japan, Malta, Mexico, Netherlands, New Zealand, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
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