Hydrocodone Bitartrate (hye-droe-KOE-done bye-TAR-trate), Pseudoephedrine Hydrochloride (soo-doe-e-FED-rin hye-droe-KLOR-ide)

Treats cough and stuffy nose. This medicine contains an opioid.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time.
• Oral liquid: Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Drink plenty of liquids to help avoid constipation.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the last 14 days.
• Some medicines can affect how hydrocodone/pseudoephedrine works. Tell your doctor if you are using any of the following:
  • Carbamazepine, digitalis, erythromycin, ketoconazole, phenytoin, rifampin, ritonavir
  • Blood pressure medicine (including mecamylamine, methyldopa, reserpine)
  • Diuretic (water pill)
  • Medicine to treat anxiety, depression, or mental health problems (including benzodiazepine medicine)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using butorphanol, nalbuphine, pentazocine, or a muscle relaxer.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, asthma, COPD, diabetes, digestion or stomach problems, heart disease, high blood pressure, Addison disease, thyroid problems, enlarged prostate, pancreas problems, or a history of head injury, seizures, or drug or alcohol use disorder.
• This medicine may cause the following problems:
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Increased risk of overdose, which can lead to death
  • Increased risk of seizures
  • Low blood pressure
  • Adrenal gland problems
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Call your doctor if your cough does not improve or if it gets worse within 5 days.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in skin color, dark freckles
• Extreme weakness, shallow breathing, slow heartbeat, sweating, cold, clammy skin
• Fast, slow, or uneven heartbeat
• Lightheadedness, dizziness, fainting
• Seizures or tremors
• Severe constipation or stomach pain
• Trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Mild tiredness, drowsiness, or sleepiness
• Mood changes, trouble sleeping
• Nausea, vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088