HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE- hydrocodone bitartrate and homatropine methylbromide syrup 
American Health Packaging

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MEDICATION GUIDE

8427867/0422F

HYDROCODONE AND HOMATROPINE (hye" droe koe' done hoe mat' roe peen)
(hydrocodone bitartrate and homatropine methylbromide) oral solution, for oral administration, CII

What is the most important information I should know about HYDROCODONE AND HOMATROPINE ORAL SOLUTION?
HYDROCODONE AND HOMATROPINE ORAL SOLUTION is not for children under 18 years of age.

HYDROCODONE AND HOMATROPINE ORAL SOLUTION can cause serious side effects, including:

  • Addiction, abuse and misuse. Taking HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 not share your HYDROCODONE AND HOMATROPINE ORAL SOLUTION with other people.
  • Keep HYDROCODONE AND HOMATROPINE ORAL SOLUTION in a safe place away from children.
  • Life-threatening breathing problems (respiratory depression). HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION, 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION exactly as prescribed by your healthcare provider.
    Call your healthcare provider or get emergency medical help right away if anyone taking HYDROCODONE AND HOMATROPINE ORAL SOLUTION has any of the symptoms below:
  • increased sleepiness
  • shallow breathing
  • confusion
  • limpness
  • difficulty breathing

Keep HYDROCODONE AND HOMATROPINE ORAL SOLUTION in a safe place away from children. Accidental use of even 1 dose of HYDROCODONE AND HOMATROPINE ORAL SOLUTION, 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION, 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION. Always use an accurate milliliter (mL) measuring device to measure the correct amount of HYDROCODONE AND HOMATROPINE ORAL SOLUTION. Do not use 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 withdrawal can happen if you start taking or stop taking other medicines while taking HYDROCODONE AND HOMATROPINE ORAL SOLUTION, 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 death can happen in people who take HYDROCODONE AND HOMATROPINE ORAL SOLUTION with benzodiazepines or other central nervous system depressants, including alcohol.
  • Do not take benzodiazepines or any medicine that can cause drowsiness or sleepiness during treatment with HYDROCODONE AND HOMATROPINE ORAL SOLUTION.
  • Do not drink alcohol or take prescription or over-the-counter medicines that contain alcohol during treatment with HYDROCODONE AND HOMATROPINE ORAL SOLUTION.
  • Opioid withdrawal in a newborn. Use of HYDROCODONE AND HOMATROPINE ORAL SOLUTION during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. You should not take HYDROCODONE AND HOMATROPINE ORAL SOLUTION if you are pregnant. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.

What is HYDROCODONE AND HOMATROPINE ORAL SOLUTION?

  • HYDROCODONE AND HOMATROPINE ORAL SOLUTION is a prescription medicine used in adults 18 years of age and older to treat a cough. HYDROCODONE AND HOMATROPINE ORAL SOLUTION contains hydrocodone, an opioid (narcotic) cough suppressant.
  • HYDROCODONE AND HOMATROPINE ORAL SOLUTION is a federal controlled substance (CII) because it contains hydrocodone that can be abused or lead to dependence. Keep HYDROCODONE AND HOMATROPINE ORAL SOLUTION in a safe place to prevent misuse and abuse. Selling or giving away HYDROCODONE AND HOMATROPINE ORAL SOLUTION may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take HYDROCODONE AND HOMATROPINE ORAL SOLUTION?
HYDROCODONE AND HOMATROPINE ORAL SOLUTION is not for children under 18 years of age. See "What is the most important information I should know about HYDROCODONE AND HOMATROPINE ORAL SOLUTION?"

Do not take HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION?"
  • have a blockage (obstruction) in your bowel such as a paralytic ileus.
  • are allergic to hydrocodone, homatropine, or any of the ingredients in HYDROCODONE AND HOMATROPINE ORAL SOLUTION. 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION, 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 problems
  • 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 glaucoma (increased pressure in eyes)
  • 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. HYDROCODONE AND HOMATROPINE ORAL SOLUTION can harm your unborn baby. See "What is the most important information I should know about HYDROCODONE AND HOMATROPINE ORAL SOLUTION?"
  • 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. You and your healthcare provider should decide if you will take HYDROCODONE AND HOMATROPINE ORAL SOLUTION or breastfeed. You should not do both. See "What should I avoid while taking HYDROCODONE AND HOMATROPINE ORAL SOLUTION?"
  • plan to have children. HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION. 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION with certain other medicines can cause side effects or affect how well HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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:

  • 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 uptake 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.

How should I take HYDROCODONE AND HOMATROPINE ORAL SOLUTION?

  • See "What is the most important information I should know about HYDROCODONE AND HOMATROPINE ORAL SOLUTION?"
  • Take HYDROCODONE AND HOMATROPINE ORAL SOLUTION exactly as your healthcare provider tells you to take it. Do not change your dose without talking to your healthcare provider.
  • Take HYDROCODONE AND HOMATROPINE ORAL SOLUTION by mouth only.
  • Take HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
  • Do not overfill the measuring device.
  • Rinse the measuring device with water after each use.
  • If you take too much HYDROCODONE AND HOMATROPINE ORAL SOLUTION, 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION.

What should I avoid while taking HYDROCODONE AND HOMATROPINE ORAL SOLUTION?

  • Avoid driving a car or operating machinery during treatment with HYDROCODONE AND HOMATROPINE ORAL SOLUTION. HYDROCODONE AND HOMATROPINE ORAL SOLUTION can cause you to be drowsy, slow your thinking and motor skills, and affect your vision.
  • Do not drink alcohol during treatment with HYDROCODONE AND HOMATROPINE ORAL SOLUTION. Drinking alcohol can increase your chances of having serious side effects.

Avoid the use of HYDROCODONE AND HOMATROPINE ORAL SOLUTION if you:

  • are pregnant. Use of HYDROCODONE AND HOMATROPINE ORAL SOLUTION in 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION. Avoid starting HYDROCODONE AND HOMATROPINE ORAL SOLUTION if you stopped taking an MAOI in the last 14 days.

What are the possible side effects of HYDROCODONE AND HOMATROPINE ORAL SOLUTION?
HYDROCODONE AND HOMATROPINE ORAL SOLUTION can cause serious side effects, including:

  • See "What is the most important information I should know about HYDROCODONE AND HOMATROPINE ORAL SOLUTION?"
  • Bowel problems including severe constipation or stomach pain. See "Who should not take HYDROCODONE AND HOMATROPINE ORAL SOLUTION?"
  • Increased pressure in your head (intracranial). Avoid the use of HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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, HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION with certain other medicines that lower blood pressure. If you have any of these symptoms while taking HYDROCODONE AND HOMATROPINE ORAL SOLUTION, sit or lie down. Do not change your body position too fast. Get up slowly from sitting or lying down.
  • Adrenal gland problems. HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION.

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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION?

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

How should I dispose of HYDROCODONE AND HOMATROPINE ORAL SOLUTION?
Remove unused HYDROCODONE AND HOMATROPINE ORAL SOLUTION 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 HYDROCODONE AND HOMATROPINE ORAL SOLUTION.

General information about the safe and effective use of HYDROCODONE AND HOMATROPINE ORAL SOLUTION.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use HYDROCODONE AND HOMATROPINE ORAL SOLUTION for a condition for which it was not prescribed. Do not give HYDROCODONE AND HOMATROPINE ORAL SOLUTION to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about HYDROCODONE AND HOMATROPINE ORAL SOLUTION that is written for health professionals.

What are the ingredients in HYDROCODONE AND HOMATROPINE ORAL SOLUTION?
Active ingredients: hydrocodone bitartrate and homatropine methylbromide
Inactive ingredients in HYDROCODONE AND HOMATROPINE ORAL SOLUTION: Caramel, NF; Cherry Flavor; D&C Red No. 33; Glycerin, USP; Liquid Sugar; Methylparaben, NF; Propylene Glycol, USP; Propylparaben, NF and Sorbitol Solution, USP. Citric Acid, USP or Sodium Citrate, USP may be added for pH adjustment.

For more information about the drug product, go to www.wockhardtusa.com or call Wockhardt USA, LLC at 1-800-346-6854.
For more information about the packaging or labeling, call American Health Packaging at 1-800-707-4621.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
American Health Packaging
Columbus, OH 43217

8427867/0422F

Revised: 2/2023
Document Id: f5b0937e-33f1-697a-e053-2995a90a2e7b
Set id: 9e5daeac-8573-48e9-877f-c08701255c5b
Version: 4
Effective Time: 20230227
American Health Packaging