Methylphenidate Oral Solution

NDC 0406-3010-50

500 mL

Methylphenidate HCl Oral Solution

CII

10 mg per 5 mL

Rx only

PHARMACIST:  Dispense the Medication Guide provided separately to each patient.

Mallinckrodt™
Pharmaceuticals

L0M142
Rev 04/2016

METHYLPHENIDATE HCL ORAL SOLUTION  methylphenidate hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0406-3005 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID   GLYCERIN   POLYETHYLENE GLYCOL 1450   WATER

Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:0406-3005-50 500 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA AUTHORIZED GENERIC NDA021419 08/01/2013

METHYLPHENIDATE HCL ORAL SOLUTION  methylphenidate hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0406-3010 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 10 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID   GLYCERIN   POLYETHYLENE GLYCOL 1450   WATER

Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:0406-3010-50 500 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA AUTHORIZED GENERIC NDA021419 08/01/2013

Labeler - Mallinckrodt, Inc. (047021092)

Establishment
Name	Address	ID/FEI	Operations
MALLINCKRODT INC		957414238	ANALYSIS(0406-3005, 0406-3010), MANUFACTURE(0406-3005, 0406-3010)

Establishment
Name	Address	ID/FEI	Operations
MALLINCKRODT, INC.		163205300	API MANUFACTURE(0406-3005, 0406-3010)

Establishment
Name	Address	ID/FEI	Operations
Whitehouse Analytical Laboratories		138628008	PACK(0406-3005, 0406-3010)

Revised: 04/2017   Mallinckrodt, Inc.

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What Are You Taking This Medication For?

Attention deficit hyperactivity disorder (ADHD)

Generic: methylphenidate

Form: Oral liquid solution Strengths: 5 mg/5 mL and 10 mg/5 mL

Brand: Methylin

Form: Oral liquid solution Strengths: 5 mg/5 mL and 10 mg/5 mL

Brand: Quillivant XR

Form: Oral suspension Strengths: 25 mg/5 mL

Oral suspension (Quillivant XR):

Adult Dosage (ages 18-64 years)

• The standard dose is 20 mg taken once per day in the morning.
• Your doctor may increase your dose by 10—20 mg each week up to a maximum of 60 mg per day.

Child Dosage (ages 6-17 years)

• The standard dose is 20 mg taken once per day in the morning.
• Your doctor may increase your dose by 10—20 mg each week.

Child Dosage (ages 0-5 years)

Dosages for people younger than 6 years haven’t been established.

Oral solution:

Adult Dosage (ages 18-64 years)

The standard dose is 20—30 mg per day taken in 2—3 divided doses up to a maximum of 60 mg per day.

Child Dosage (ages 6-17 years)

• The standard dose is 5 mg taken twice each day before breakfast and lunch.
• Your doctor may increase your dose by 5—10 mg each week.

Child Dosage (ages 0-5 years)

Dosages for people younger than 6 years haven’t been established.

Warnings

Methylphenidate shouldn’t be taken late at night because it may cause trouble sleeping.

Narcolepsy

Generic: methylphenidate

Form: Oral liquid solution Strengths: 5 mg/5 mL and 10 mg/5 mL

Brand: Methylin

Form: Oral liquid solution Strengths: 5 mg/5 mL and 10 mg/5 mL Adult Dosage (ages 18-64 years)

The standard dose is 20—30 mg per day taken in 2—3 divided doses.

Child Dosage (ages 6-17 years)

• The standard dose is 5 mg taken twice each day before breakfast and lunch.
• Your doctor may increase your dose by 5—10 mg each week.

Child Dosage (ages 0-5 years)

Dosages for people younger than 6 years haven’t been established.

Warnings

Methylphenidate shouldn’t be taken late at night because it may cause trouble sleeping.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you. Important Considerations for Taking Methylphenidate

Certain forms shouldn’t be taken with food

See Details

Each form may be stored differently

See Details

Prescription is not refillable

Travel

See Details

Self-Management

See Details

Clinical Monitoring

See Details

Not every pharmacy stocks all forms of methylphenidate, so call ahead

Insurance

See Details

Are There Any Alternatives?