Mydayis ER Capsules

Name: Mydayis ER Capsules

Dosage Forms and Strengths

  • Extended-release capsules 12.5 mg: green body/green cap (imprinted with SHIRE 465 and 12.5 mg)
  • Extended-release capsules 25 mg: ivory body/green cap (imprinted with SHIRE 465 and 25 mg)
  • Extended-release capsules 37.5 mg: ivory body/light caramel cap (imprinted with SHIRE 465 and 37.5 mg)
  • Extended-release capsules 50 mg: ivory body/purple cap (imprinted with SHIRE 465 and 50 mg)

Drug Interactions

Drugs Having Clinically Important Interactions with Amphetamines

Table 3 Drugs Having Clinically Important Interactions with Amphetamines
MAO Inhibitors (MAOI)
Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Intervention Do not administer MYDAYIS during or within 14 days following the administration of MAOI [see Contraindications (4)].
Examples selegiline, isocarboxazid, phenelzine, tranylcypromine
Serotonergic Drugs
Clinical Impact The concomitant use of amphetamines and serotonergic drugs increases the risk of serotonin syndrome.
Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during MYDAYIS initiation or dosage increase. If serotonin syndrome occurs, discontinue MYDAYIS and concomitant serotonergic drug(s) [see Warnings and Precautions 5.7].
Examples Selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort
Alkalinizing Agents
Clinical Impact May increase exposure to amphetamine and exacerbate the action of amphetamine.
Intervention Caution should be taken when co-administering MYDAYIS and gastrointestinal and urinary alkalinizing agents.
Examples Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate; proton pump inhibitors [e.g. omeprazole])
Urinary alkalinizing agents (e.g. acetazolamide, some thiazides)
Acidifying Agents
Clinical Impact Lower blood levels and efficacy of amphetamines.
Intervention Increase dose of MYDAYIS based on clinical response.
Examples Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid)
Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts)
Tricyclic Antidepressants
Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.
Intervention Monitor frequently and adjust MYDAYIS dose or use alternative therapy based on clinical response.
Examples desipramine, protriptyline
CYP2D6 Inhibitors
Clinical Impact May increase the exposure of amphetamine
Intervention Start with lower doses and monitor frequently and adjust MYDAYIS dose or use alternative therapy based on clinical response.
Examples paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.
Gastric pH Modulators
Clinical Impact Potential change in shape of PK profile and exposure may occur
Intervention Monitor patients for changes in clinical effect and use alternative therapy based on clinical response.
Examples omeprazole, esomeprazole, pantoprazole, cimetidine

Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

Drug Abuse and Dependence

Controlled Substance

MYDAYIS contains mixed amphetamine salts, which are in Schedule II.

Abuse

MYDAYIS is a CNS stimulant that contains mixed amphetamine salts which have a high potential for abuse. Abuse is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving.

Signs and symptoms of amphetamine abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been seen. Abusers of amphetamine may use unapproved routes of administration which can result in overdose and death [see Overdosage (10)].

To reduce the abuse of CNS stimulants, including MYDAYIS, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants. Monitor for signs of abuse while on therapy, and re-evaluate the need for MYDAYIS use.

Dependence

Tolerance

Tolerance (a state of adaptation in which exposure to a specific dose of a drug results in a reduction of the drug's desired and/or undesired effects over time, in such a way that a higher dose of the drug is required to produce the same effect that was once obtained at a lower dose) may occur during the chronic therapy of CNS stimulants including MYDAYIS.

Dependence

Physical dependence (a state of adaptation manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including MYDAYIS. Withdrawal symptoms after abrupt cessation of CNS stimulants include extreme fatigue and depression.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Controlled Substance Status/High Potential for Abuse and Dependence

Advise patients and their caregivers that MYDAYIS is a federally controlled substance because it can be abused or lead to dependence. Advise patients to store MYDAYIS in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired MYDAYIS by a medicine take-back program if available [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9)].

Serious Cardiovascular Risks

Advise patients, caregivers, and family members that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with MYDAYIS use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Blood Pressure and Heart Rate Increases

Instruct patients that MYDAYIS can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects [see Warnings and Precautions (5.3)].

Psychiatric Risks

Advise patients that MYDAYIS, at recommended doses, may cause psychotic or manic symptoms even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Long-Term Suppression of Growth

Advise patients, family members, and caregivers that amphetamines may cause slowing of growth including weight loss [see Warnings and Precautions (5.5)].

Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud's Phenomenon]

Instruct patients beginning treatment with MYDAYIS about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking MYDAYIS. Further clinical evaluation (e.g. rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)].

Seizures

Caution patient that MYDAYIS may lower the convulsive threshold. Advise patients to contact their healthcare provider immediately and to discontinue MYDAYIS if a seizure occurs [see Warnings and Precautions (5.7)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with concomitant use of MYDAYIS and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications (4), Warnings and Precautions (5.8) and Drug Interactions (7.1)]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.

Concomitant Medications

Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1)].

Pregnancy

Advise patients of the potential fetal effects from the use of MYDAYIS during pregnancy. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with MYDAYIS [see Use in Specific Populations (8.1)].

Lactation

Advise women not to breastfeed if they are taking MYDAYIS [see Use in Specific Populations (8.2)].

Alcohol

Advise patients to avoid alcohol while taking MYDAYIS. Consumption of alcohol while taking MYDAYIS may result in a more rapid release of the dose of mixed amphetamine salts [see Clinical Pharmacology (12.3)].

Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421

Made in USA

For more information call 1-800-828-2088

MYDAYIS is a trademark of Shire LLC

©2017 Shire. All rights reserved.

US Pat No. RE41148, US Pat No. RE42096, US Pat. No. US 6913768, US Pat. No. 8,846,100, and US Pat. No. 9,173,857

MEDICATION GUIDE
MYDAYIS (my-DAY-is)
(mixed salts of a single-entity amphetamine product)
extended-release capsules, CII
  This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 06/2017
What is the most important information I should know about MYDAYIS?
MYDAYIS can cause serious side effects, including:
  • Abuse and dependence. MYDAYIS, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with MYDAYIS.
  • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs.
  • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
  • Heart-related problems, including:
    • sudden death, stroke, and heart attack in adults
    • sudden death in people who have heart problems or heart defects
    • increased blood pressure and heart rate
    Your healthcare provider should check you or your child carefully for heart problems before starting MYDAYIS. Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
    Your healthcare provider should check you or your child's blood pressure and heart rate regularly during treatment with MYDAYIS.
    Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with MYDAYIS.
  • Mental (psychiatric) problems, including:
    • new or worse behavior and thought problems
    • new or worse bipolar illness
    • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
    Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
    Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking MYDAYIS, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
What is MYDAYIS?
MYDAYIS is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 13 years of age and older.
  • MYDAYIS is not for use in children 12 years of age and younger.
  • MYDAYIS is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep MYDAYIS in a safe place to protect it from theft. Never give MYDAYIS to anyone else, because it may cause death or harm them. Selling or giving away MYDAYIS may harm others and is against the law.
Do not take MYDAYIS if you or your child are:
  • allergic to amphetamine or any of the ingredients in MYDAYIS. See the end of the Medication Guide for a complete list of ingredients in MYDAYIS.
  • taking, or have taken within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
Before taking MYDAYIS, tell your or your healthcare provider about all medical conditions, including if you or your child:
  • have heart problems, heart defects or high blood pressure
  • have mental problems including psychosis, mania, bipolar illness or depression, or have a family history of suicide
  • have circulation problems in fingers and toes
  • have or have had seizures
  • have kidney problems. You should not take MYDAYIS if you have end stage renal disease (ESRD).
  • are pregnant or plan to become pregnant. It is not known if MYDAYIS will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with MYDAYIS.
  • are breastfeeding or plan to breastfeed. MYDAYIS passes into breast milk. You should not breastfeed during treatment with MYDAYIS.
Tell your healthcare provider about all the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
MYDAYIS may affect the way other medicines work and other medicines may affect how MYDAYIS works. Taking MYDAYIS with other medicines can cause serious side effects.
Especially tell your healthcare provider if you or your child take medicines used to treat depression including MAOIs.
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your or your child's healthcare provider and pharmacist when you or your child get a new medicine.
Your healthcare provider will decide whether MYDAYIS can be taken with other medicines. Do not start any new medicine during treatment with MYDAYIS without talking to your or your child's healthcare provider first.
How should I take MYDAYIS?
  • Take MYDAYIS exactly as prescribed by your healthcare provider.
  • Your healthcare provider may change the dose if needed.
  • Take MYDAYIS 1 time each day in the morning right after you wake-up. MYDAYIS may last up to 16 hours and can cause difficulty sleeping.
  • If you miss a dose of MYDAYIS, do not take your dose later in the day or double your dose to make up for a missed dose. Take your MYDAYIS dose the next morning at your regularly scheduled time.
  • MYDAYIS can be taken with or without food but take it the same way each time.
  • MYDAYIS capsules may be swallowed whole or if MYDAYIS capsules cannot be swallowed whole, the capsules may be opened and sprinkled over a spoonful of applesauce.
    • swallow all of the applesauce and medicine mixture right away
    • do not chew the applesauce and medicine mixture
    • do not store the sprinkled applesauce
  • Your healthcare provider may sometimes stop MYDAYIS treatment for a while to check ADHD symptoms.
  • If you or your child takes too much MYDAYIS, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid during treatment with MYDAYIS?
You should avoid drinking alcohol during treatment with MYDAYIS.
What are possible side effects of MYDAYIS?
MYDAYIS can cause serious side effects, including:
  • See "What is the most important information I should know about MYDAYIS?"
  • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with MYDAYIS. Your healthcare provider may stop your child's MYDAYIS treatment if they are not growing or gaining weight as expected.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Signs and symptoms may include:
    • fingers or toes may feel numb, cool, painful
    • fingers or toes may change color from pale, to blue, to red
    Tell your healthcare provider if you have or your child has any numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
    Call your healthcare provider if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with MYDAYIS.
  • Seizures. Your healthcare provider will stop treatment with MYDAYIS if you have a seizure.
  • Serotonin syndrome. This problem may happen when MYDAYIS is taken with certain other medicines and may be life-threatening. Call your healthcare provider or go to the nearest hospital emergency room if you get symptoms of serotonin syndrome which may include:
  • agitation, hallucinations, coma, or other changes in mental status
  • problems controlling your movements or muscle twitching
  • fast heartbeat
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle stiffness or tightness
  The most common side effects of MYDAYIS include:
  • trouble sleeping
  • decreased appetite
  • dry mouth
  • increased heart rate
  • anxiety
  • nausea
  • irritability
  • weight loss
These are not all the possible side effects of MYDAYIS.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store MYDAYIS?
  • Store MYDAYIS at room temperature between 68°F to 77°F (20°C to 25°C).
  • Protect MYDAYIS from light.
  • Store MYDAYIS in a safe place, like a locked cabinet.
  • Dispose of remaining, unused, or expired MYDAYIS by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix MYDAYIS with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away MYDAYIS in the household trash.
Keep MYDAYIS and all medicines out of the reach of children.
General information about the safe and effective use of MYDAYIS
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use MYDAYIS for a condition for which it was not prescribed. Do not give MYDAYIS to other people, even if they have the same condition. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about MYDAYIS that was written for healthcare professionals.
What are the ingredients in MYDAYIS?
Active ingredients: dextroamphetamine sulfate and amphetamine sulfate, dextroamphetamine saccharate and amphetamine aspartate monohydrate
Inactive ingredients: hard gelatin capsules, ethylcellulose, hydroxypropyl methylcellulose, methacrylic acid copolymer, methyl acrylate, methyl methacrylate, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain gelatin, titanium dioxide, yellow iron oxide and edible inks. The 12.5 mg and 25 mg capsules also contain FD&C Blue #2. The 37.5 mg also contains red iron oxide. The 50 mg capsule also contains D&C Red #28, D&C Red #33, and FD&C Blue #1.
Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
MYDAYIS is a trademark of Shire LLC., ©2017 Shire. All rights reserved.
For more information about MYDAYIS go to www.mydayis.com or call 1-800-828-2088.

PRINCIPAL DISPLAY PANEL - 12.5 mg Capsule Bottle Label

ONCE-DAILY
NDC 54092-468-01

Mydayis™

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

12.5 mg

100 Capsules

Do not substitute for Adderall XR.

CII Rx only

Shire

018576

LOT
EXP.

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label

ONCE-DAILY
NDC 54092-477-01

Mydayis™

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

50 mg

100 Capsules

Do not substitute for Adderall XR.

CII Rx only

Shire

018579

LOT
EXP.

MYDAYIS 
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-468
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 3.125 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 3.125 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 3.125 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 3.125 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
FD&C BLUE NO. 2  
FERRIC OXIDE YELLOW  
TITANIUM DIOXIDE  
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code SHIRE;465;12;5mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-468-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022063 06/20/2017
MYDAYIS 
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-471
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 6.25 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 6.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 6.25 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
FD&C BLUE NO. 2  
FERRIC OXIDE YELLOW  
TITANIUM DIOXIDE  
Product Characteristics
Color GREEN, WHITE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code SHIRE;465;25mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-471-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022063 06/20/2017
MYDAYIS 
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-474
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 9.375 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 9.375 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 9.375 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 9.375 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
TITANIUM DIOXIDE  
Product Characteristics
Color BROWN, WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code SHIRE;465;37;5mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-474-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022063 06/20/2017
MYDAYIS 
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-477
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 12.5 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 12.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 12.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
D&C RED NO. 28  
D&C RED NO. 33  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
Product Characteristics
Color WHITE, PURPLE Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code SHIRE;465;50mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-477-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022063 06/20/2017
Labeler - Shire US Manufacturing Inc. (964907406)
Establishment
Name Address ID/FEI Operations
Cambrex Charles City, Inc 782974257 ANALYSIS(54092-468, 54092-471, 54092-474, 54092-477), API MANUFACTURE(54092-468, 54092-471, 54092-474, 54092-477), PACK(54092-468, 54092-471, 54092-474, 54092-477)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services LLC 079415560 ANALYSIS(54092-468, 54092-471, 54092-474, 54092-477), LABEL(54092-468, 54092-471, 54092-474, 54092-477), MANUFACTURE(54092-468, 54092-471, 54092-474, 54092-477), PACK(54092-468, 54092-471, 54092-474, 54092-477)
Revised: 06/2017   Shire US Manufacturing Inc.
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