What is the most important information I should know about OBREDON?

OBREDON is not for children under 18 years of age.

OBREDON can cause serious side effects, including:

• Addiction, abuse and misuse.Taking OBREDON or other medicines that contain an opioid can cause addiction, abuse and misuse, which can lead to overdose and death. This can happen even if you take OBREDON exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems.
  • Do notshare your OBREDON with other people.
  • Keep OBREDON in a safe place away from children.
• Life-threatening breathing problems (respiratory depression).OBREDON can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking OBREDON, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly or have certain other health problems. Children are at higher risk for respiratory depression.Breathing problems can happen even if you take OBREDON exactly as prescribed by your healthcare provider.
  Call your healthcare provider or get emergency medical help right away if anyone taking OBREDON has any of the symptoms below:
  • increased sleepiness
  • confusion
  • difficulty breathing
  • shallow breathing
  • limpness
• Keep OBREDON in a safe place away from children.Accidental use of even 1 dose of OBREDON, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. If a child accidentally takes OBREDON, get emergency medical help right away.
• Overdose and death due to medicine dosing errors.Overdose and death can happen if you measure the wrong dose of OBREDON. Always use an accurate milliliter (mL) measuring device to measure the correct amount of OBREDON. Do notuse a household teaspoon to measure your medicine. You may accidentally take too much. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose.
• Breathing problems (respiratory depression) that can lead to death and opioid withdrawalcan happen if you start taking or stop taking other medicines while taking OBREDON, including:
  • certain antibiotics
  • certain medicines to treat a fungal infection
  • certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C
  • rifampin
  • carbamazepine
  • phenytoin
    Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above.
• Severe drowsiness, breathing problems (respiratory depression), coma and deathcan happen in people who take OBREDON with benzodiazepines or other central nervous system depressants, including alcohol.
  • Do nottake benzodiazepines or any medicine that can cause drowsiness or sleepiness during treatment with OBREDON.
  • Do notdrink alcohol or take prescription or over-the-counter medicines that contain alcohol during treatment with OBREDON.
• Opioid withdrawal in a newborn.Use of OBREDON during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. You should not take OBREDON if you are pregnant. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.

What is OBREDON?

• OBREDON is a prescription medicine used in adults to treat a cough and to loosen mucus that you can have with a common cold. OBREDON contains 2 medicines, hydrocodone and guaifenesin. Hydrocodone is an opioid (narcotic) cough suppressant. Guaifenesin is an expectorant.
• OBREDON is a federal controlled substance (C-II) because it contains hydrocodone that can be abused or lead to dependence.Keep OBREDON in a safe place to prevent misuse and abuse. Selling or giving away OBREDON may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take OBREDON?

OBREDON is not for children under 18 years of age.See “What is the most important information I should know about OBREDON?”

Do not take OBREDON if you:

• have severe breathing problems (respiratory depression) or breathing problems caused by asthma. See “ What is the most important information I should know about OBREDON?”
• have a blockage (obstruction) in your bowel such as a paralytic ileus.
• are allergic to hydrocodone, guaifenesin, or any of the ingredients in OBREDON. See the end of this Medication Guide for a complete list of ingredients.

Ask your healthcare provider if you have any questions about this information.

Before you take OBREDON, tell your healthcare provider about all of your medical conditions, including if you:

• have a drug addiction
• have lung or breathing problems
• have a fever and are coughing up mucus
• have had a recent head injury
• have had a brain tumor or other brain problem
• have or have had seizures
• have pain in your stomach-area (abdomen)
• have constipation or other bowel problems
• have bile duct or pancreas problems
• have prostate problems
• have problems with your urinary tract or difficulty urinating
• have kidney or liver problems
• have adrenal gland problems
• have low blood pressure
• plan to have surgery
• are pregnant or plan to become pregnant. OBREDON can harm your unborn baby. See “What is the most important information I should know about OBREDON?”
• are breastfeeding or plan to breastfeed. Hydrocodone passes into your breast milk and can cause serious side effects in your baby including increased sleepiness, breathing problems (respiratory depression), and death. It is not known if guaifenesin passes into your breast milk. You and your healthcare provider should decide if you will take OBREDON or breastfeed. You should not do both.
• plan to have children. OBREDON may affect the ability to have a child in females and males (fertility problems). It is not known if these fertility problems will be reversible, even after you stop taking OBREDON. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking OBREDON with certain other medicines can cause side effects or affect how well OBREDON or the other medicines work. Do not start or stop taking other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

• See “What is the most important information I should know about OBREDON?”
• take pain medicines such as opioids (narcotics).
• take cold or allergy medicines that contain antihistamines or cough suppressants.
• drink alcohol.
• take muscle relaxants.
• take certain medicines used to treat mood, anxiety, psychotic or thought disorders, or depression, including monoamine oxidase inhibitors (MAOIs), tricyclics, selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), or antipsychotics.
• take medicines to lower your blood pressure.
• take water pills (diuretics).
• take medicines called “anticholinergics” used to treat certain health problems including asthma, chronic obstructive pulmonary disease (COPD), or stomach problems.

Ask your healthcare provider if you are not sure if you take one of these medicines.

• See “What is the most important information I should know about OBREDON?”
• Take OBREDON exactly as your healthcare provider tells you to take it. Do not change your dose without talking to your healthcare provider.
• Take OBREDON by mouth only.
• Take OBREDON using an accurate milliliter (mL) measuring device. If you do not have one, ask your pharmacist to give you a measuring device to help you measure the correct amount of OBREDON. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
• Do notoverfill the measuring device.
• Rinse your measuring device with water after each use.
• If you take too much OBREDON, call your healthcare provider or go to the nearest hospital emergency room right away.
• Tell your healthcare provider if your cough does not get better within 5 days of treatment with OBREDON.

• Avoid driving a car or operating machinery during treatment with OBREDON. OBREDON can cause you to be drowsy, slow your thinking and motor skills, and may affect your vision.
• Do notdrink alcohol during treatment with OBREDON. Drinking alcohol can increase your chances of having serious side effects.

• are pregnant. Use of OBREDON during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.
• are breastfeeding. Use of OBREDON while breastfeeding can cause severe breathing problems (respiratory depression) in your breastfed infant that could be life-threatening.
• take a medicine called a monoamine oxidase inhibitor (MAOI). Avoid taking an MAOI within 14 days after you stop taking OBREDON. Avoid starting OBREDON if you stopped taking an MAOI in the last 14 days.

What are the possible side effects of OBREDON?

OBREDON can cause serious side effects, including:

• See “What is the most important information I should know about OBREDON?”
• Bowel problems including severe constipation or stomach pain.See “ Who should not take OBREDON?”
• Increased pressure in your head (intracranial).Avoid the use of OBREDON if you have a head injury or have been told that you have changes in the tissue of your brain (brain lesions) or increased pressure in your head.
• Increased risk of seizures in people with seizure disorders.If you have a seizure disorder, OBREDON may increase how often you have a seizure.
• Low blood pressure.A sudden drop in blood pressure can happen in some people during treatment with OBREDON and this may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). Your risk of having this problem may be increased if you take OBREDON with certain other medicines that lower blood pressure. If you have any of these symptoms while taking OBREDON, sit or lie down. Do not change your body position too fast. Get up slowly from sitting or lying down.
• Adrenal gland problems.OBREDON can cause serious and life-threatening adrenal gland problems. Your healthcare provider may do blood tests to check for adrenal gland problems. Call your healthcare provider right away if you have any of these symptoms:
  • nausea
  • vomiting
  • not wanting to eat (anorexia)
  • fatigue
  • weakness
  • dizziness
  • low blood pressure

The most common side effects of OBREDON include:

• sleepiness
• confusion
• coordination problems
• decrease in mental and physical performance
• lack of energy
• lightheadedness
• dizziness
• headache
• dry mouth
• nausea
• vomiting
• constipation

These are not all the possible side effects of OBREDON.

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 OBREDON?

• Store OBREDON at room temperature between 20°F to 25°F (68°C to 77°C).
• Store OBREDON in a tightly closed container, in a dry, cool place away from heat or direct sunlight.
• Keep OBREDON and all medicines out of the reach of children.

How should I dispose of OBREDON?

Remove unused OBREDON from the container and mix it with an undesirable, non-toxic substance such as 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 it away in the household trash. You can also follow your state or local guidelines on how to safely throw away OBREDON.

What are the ingredients in OBREDON?

Active ingredients:hydrocodone bitartrate and guaifenesin

Inactive ingredients:artificial raspberry flavor, citric acid, glycerin, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, and saccharin sodium.

Manufactured by: Sovereign Pharmaceuticals, LLC, Fort Worth, TX 76118
For more information, call 1-855-461-5102.