DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate tablet
SpecGx LLC
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MEDICATION GUIDE |
What is the most important information I should know about Mixed Salts of a Single Entity Amphetamine Product? Mixed Salts of a Single Entity Amphetamine Product may cause serious side effects, including:
Your healthcare provider should check you or your child carefully for heart problems before starting treatment with Mixed Salts of a Single Entity Amphetamine Product. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Mixed Salts of a Single Entity Amphetamine Product.
Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Mixed Salts of a Single Entity Amphetamine Product.
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 during treatment with Mixed Salts of a Single Entity Amphetamine Product, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. |
What are Mixed Salts of a Single Entity Amphetamine Product? Mixed Salts of a Single Entity Amphetamine Product are a central nervous system (CNS) stimulant prescription medicine used for the treatment of:
It is not known if Mixed Salts of a Single Entity Amphetamine Product is safe and effective in children with ADHD under 3 years of age. It is not known if Mixed Salts of a Single Entity Amphetamine Product is safe and effective in children with narcolepsy under 6 years of age. Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product in a safe place to protect it from theft. Never give your Mixed Salts of a Single Entity Amphetamine Product to anyone else because it may cause death or harm them. Selling or giving away Mixed Salts of a Single Entity Amphetamine Product may harm others and is against the law. |
Do not take Mixed Salts of a Single Entity Amphetamine Product if you or your child:
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Before taking Mixed Salts of a Single Entity Amphetamine Product tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:
Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Mixed Salts of a Single Entity Amphetamine Product and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with Mixed Salts of a Single Entity Amphetamine Product. Your healthcare provider will decide if Mixed Salts of a Single Entity Amphetamine Product can be taken with other medicines. Especially tell your healthcare provider if you or your child take:
Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine. Do not start any new medicine during treatment with Mixed Salts of a Single Entity Amphetamine Product without talking to your healthcare provider first. |
How should Mixed Salts of a Single Entity Amphetamine Product be taken?
If you or your child take too much Mixed Salts of a Single Entity Amphetamine Product call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. |
What should I avoid while taking Mixed Salts of a Single Entity Amphetamine Product? Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how Mixed Salts of a Single Entity Amphetamine Product affects you. |
What are possible side effects of Mixed Salts of a Single Entity Amphetamine Product? Mixed Salts of a Single Entity Amphetamine Product may cause serious side effects, including: See “What is the most important information I should know about Mixed Salts of a Single Entity Amphetamine Product?”.
Signs and symptoms may include:
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 right away if you have or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Mixed Salts of a Single Entity Amphetamine Product.
The most common side effects of Mixed Salts of a Single Entity Amphetamine Product include:
Talk to your doctor if you or your child have side effects that are bothersome or do not go away. These are not all of the possible side effects of Mixed Salts of a Single Entity Amphetamine Product. 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 Mixed Salts of a Single Entity Amphetamine Product?
Keep Mixed Salts of a Single Entity Amphetamine Product and all medicines out of the reach of children.
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General information about the safe and effective use of Mixed Salts of a Single Entity Amphetamine Product Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Mixed Salts of a Single Entity Amphetamine Product for a condition for which they were not prescribed. Do not give Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product that is written for healthcare professionals. |
What are the ingredients in Mixed Salts of a Single Entity Amphetamine Product? Active Ingredients: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate Inactive Ingredients: microcrystalline cellulose, silicon dioxide, povidone and stearic acid For more information about Mixed Salts of a Single Entity Amphetamine Product, please contact Mallinckrodt at 1-800-778-7898. Manufactured by: SpecGx LLC, Webster Groves, MO 63119 USA |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised 10/2023
L20D11