Narcotic-analgesic/acetaminophen (By mouth)

Dvorah, Endocet, Lorcet, Lorcet HD, Lorcet Plus, Lortab 10/325, Lortab 5/325, Lortab 7.5/325, Lortab Elixir, Nalocet, Norco, Percocet, Primlev, Trezix, Tylenol With Codeine No. 4

Liquid, Tablet, Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
• Drink plenty of liquids to help avoid constipation.

If a dose is missed:

• Some of these medicines need to be used on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor pharmacist for instructions. Do not use 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. Do not refrigerate or freeze the medicine.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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

• Make sure your doctor knows if you are using a monoamine oxidase inhibitor (MAOI) medicine, such as Eldepryl®, Marplan®, Nardil®, or Parnate®. Make sure your doctor knows if you are also using a medicine to treat depression, such as amitriptyline, doxepin, nortriptyline, Elavil®, Pamelor®, or Sinequan®. Make sure your doctor knows if you are taking an anticholinergic medicine, such as atropine, methscopolamine, or scopolamine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

• Make sure your doctor knows if you are pregnant or breast feeding, or if you have a head injury, or other conditions that may cause an increase in intercranial pressure (pressure inside your head). Make sure your doctor knows if you have severe kidney problems or severe liver problems, or if you have hypothyroidism (lack of thyroid function). Make sure your doctor knows if you have Addison's disease (adrenal gland disease), or if you have enlarged prostate or urethral stricture. Make sure your doctor knows if you have any abdominal problems, or if you have lung disease or asthma.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or anything else that could be dangerous if you are not alert.
• 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.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• When a mother is breastfeeding and takes codeine, there is a very small chance that this medicine could cause serious side effects in the baby. This is because codeine works differently in a few women, so their breast milk contains too much medicine. If you take codeine, be alert for these signs of overdose in your nursing baby: sleeping more than usual, trouble breastfeeding, trouble breathing, or being limp and weak. Call the baby's doctor right away if you think there is a problem. If you cannot talk to the doctor, take the baby to the emergency room or call 911.

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
• Dizziness.
• Seeing or hearing things that are not there.
• Very slow heartbeat.

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

• Change in how much or how often you urinate.
• Cold, clammy skin.
• Feeling unusually anxious, excited, fearful, or tired.
• Nausea, vomiting, constipation, stomach pain or upset, or heartburn.
• Skin rash.
• Vision changes.

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