OXYCODONE HYDROCHLORIDE - oxycodone hydrochloride solution 
Novel Laboratories, Inc.

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MEDICATION GUIDE

Oxycodone Hydrochloride (ox-ee-CO-dohn) (CII) Oral Solution

IMPORTANT: Keep Oxycodone Hydrochloride Oral Solution in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes Oxycodone Hydrochloride Oral Solution, get emergency help right away.

Read the Medication Guide that comes with Oxycodone Hydrochloride Oral Solution before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Oxycodone Hydrochloride Oral Solution?

Oxycodone Hydrochloride Oral solution can cause serious side effects, including, death.

  1. Take Oxycodone Hydrochloride Oral Solution exactly as prescribed by your healthcare provider. If you take the wrong dose or strength of Oxycodone Hydrochloride Oral Solution, you could overdose and die.
  2. It is especially important when you take Oxycodone Hydrochloride Oral Solution that you know exactly what dose and strength to take, and the right way to measure your medicine. Your healthcare provider or pharmacist should show you the right way to measure your medicine.
  3. Oral Syringe. Always use the oral syringe provided with Oxycodone Hydrochloride Oral Solution, 100 mg per 5 mL (20 mg per mL) to help make sure you measure the right amount.
  4. Do not drink alcohol. Using alcohol with Oxycodone Hydrochloride Oral Solution may increase your risk of dangerous side effects, including death.
  5. Opioid Tolerance. Do not take Oxycodone Hydrochloride Oral Solution, 100 mg per 5 mL (20 mg per mL), unless you are “opioid tolerant.” Opioid tolerant means that you take another opioid medicine for your constant (around the clock) pain and your body is used to it.

What is Oxycodone Hydrochloride Oral Solution?

Oxycodone Hydrochloride Oral Solution is in a group of drugs called narcotic pain relievers.

Oxycodone Hydrochloride Oral Solution is only for adults who have moderate to severe pain.

Who should not take Oxycodone Hydrochloride Oral Solution?

Do not take Oxycodone Hydrochloride Oral Solution if you:

What should I tell my healthcare provider before taking Oxycodone Hydrochloride Oral Solution?

Before taking Oxycodone Hydrochloride Oral Solution, tell your healthcare provider if you:

If you take Oxycodone Hydrochloride Oral Solution regularly before your baby is born, your newborn baby may have signs of withdrawal because their body has become used to the medicine. Signs of withdrawal in a newborn baby can include:

If you are taking Oxycodone Hydrochloride Oral Solution right before your baby is born, your baby could have breathing problems.

Ask your healthcare provider if you are not sure if your medicine is one listed above.

What should I avoid while taking Oxycodone Hydrochloride Oral Solution?

What are the possible side effects of Oxycodone Hydrochloride Oral Solution?

Oxycodone Hydrochloride Oral Solution can cause serious side effects, including:

These can be symptoms that you have taken too much Oxycodone Hydrochloride Oral Solution (overdose) or the dose is too high for you.

These symptoms may lead to serious problems or death if not treated right away.

Call your healthcare provider if you have any of the symptoms listed above.

Common side effects of Oxycodone Hydrochloride Oral Solution include:

Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including Oxycodone Hydrochloride Oral Solution. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Oxycodone Hydrochloride Oral Solution.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Oxycodone Hydrochloride Oral Solution. For more information, ask your healthcare provider or pharmacist.

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 Oxycodone Hydrochloride Oral Solution?

Keep Oxycodone Hydrochloride Oral Solution out of the reach of children. Accidental overdose by a child is a medical emergency and can lead to death.

General information about Oxycodone Hydrochloride Oral Solution

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Oxycodone Hydrochloride Oral Solution for a condition for which it was not prescribed.

Do not give your Oxycodone Hydrochloride Oral Solution to other people, even if they have the same symptoms you have. Selling or giving away Oxycodone Hydrochloride Oral Solution may harm others, may cause death, and is against the law.

This Medication Guide summarizes the most important information about Oxycodone Hydrochloride Oral Solution. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Oxycodone Hydrochloride Oral Solution that is written for healthcare professionals.

For more information about Oxycodone Hydrochloride Oral Solution, call Novel Laboratories, Inc. at 1-866-403-7592.

What are the ingredients in Oxycodone Hydrochloride Oral Solution?

Active ingredient: oxycodone hydrochloride

Inactive ingredients: 100 mg per 5 mL contains citric acid anhydrous, D&C Yellow #10, natural/artificial mixed berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, and sorbitol solution.

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

PI9206000102

Rev. 02/2015

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

Patient Instructions for Use

Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL) Oral Syringe

Important information about measuring Oxycodone Hydrochloride Oral Solution

Step 1. Insert the tip of the oral syringe into the medicine bottle.

Step 2. Pull back the plunger to the line that matches the dose prescribed by your healthcare provider.

Step 3. Remove the oral syringe from the medicine bottle.

Step 4. Take your medicine by slowly pushing the plunger until the oral syringe is empty.

FIGURE 1

f7978574-figure-02
Revised: 5/2015
Novel Laboratories, Inc.