Acetaminophen/Hydrocodone is used for:

Treatment of moderate to moderately severe pain. It may also
be used for other conditions as determined by your doctor.

Acetaminophen/Hydrocodone is an analgesic combination.
Acetaminophen works by lowering a chemical in the brain that stimulates pain
nerves. Hydrocodone, an opioid (narcotic) analgesic, works by binding to
receptors in the brain and nervous system used by the body’s natural "pain
relievers." The combination may provide better pain relief
than either medicine alone.

Do NOT use Acetaminophen/Hydrocodone if:

• you are allergic
  to any ingredient in Acetaminophen/Hydrocodone or any other codeine- or
  morphine-related medicine (eg, codeine, oxycodone)

• you have diarrhea associated with
  poisoning, antibiotic use, or a bacterial infection (from eating or drinking
  contaminated food
  or water)

• you are taking sodium oxybate (GHB)

Before using Acetaminophen/Hydrocodone :

Some medical conditions may interact with Acetaminophen/Hydrocodone
. Tell your doctor or pharmacist if you have any medical conditions, especially
if any of the following apply to you:

• if you are pregnant, planning to
  become pregnant, or are breast-feeding

• if you are taking any
  prescription or nonprescription medicine, herbal preparation, or dietary
  supplement

• if you have allergies to
  medicines, foods,
  or other substances

• if you are allergic to codeine or
  a hydrocodone-related medicine (eg, codeine, dihydrocodeine, oxycodone)

• if you have or have ever had
  alcoholism, substance abuse, narcotic dependence, or if you consume more
  than 3 alcoholic drinks per day

• if you have considered or
  attempted suicide

• if you have acute head injury,
  increased pressure in the head, brain injury or tumor, epilepsy, or seizures
  (convulsions)

• if you are having an asthma
  attack

• if you have an acute stomach
  or intestinal problem, chronic inflammation and ulceration of the bowel, or
  recent abdominal surgery; adrenal gland problems; enlargement of the
  prostate gland; heart failure or lung disease, including shortness of
  breath; liver or kidney problems; thyroid disease; urinary blockage; or
  viral hepatitis

Some MEDICINES MAY INTERACT with Acetaminophen/Hydrocodone .
Tell your health care provider if you are taking any other medicines, especially
any of the following:

• Barbiturate anesthetics (eg,
  thiopental), cimetidine, monoamine oxidase (MAO) inhibitors (eg, phenelzine),
  tricyclic antidepressants (eg, amitriptyline), or sodium oxybate (GHB)
  because serious side effects, such as increased sleepiness and decreased
  ability to breathe, may occur

• Naltrexone because it may
  decrease Acetaminophen/Hydrocodone ‘s effectiveness and withdrawal symptoms
  may occur in patients who have become physically dependent on opioids

How to use Acetaminophen/Hydrocodone :

Use Acetaminophen/Hydrocodone as directed by your doctor.
Check the label on the medicine for exact dosing instructions.

• Take Acetaminophen/Hydrocodone by
  mouth
  with or without food. If stomach upset occurs, take with food to reduce
  stomach irritation.

• If you miss a dose of
  Acetaminophen/Hydrocodone , take it as soon as possible. If it is almost
  time for your next dose, skip the missed dose and go back to your regular
  dosing schedule. Do not take 2 doses at once.

Important safety information:

• Acetaminophen/Hydrocodone may
  cause drowsiness, dizziness, blurred vision, or lightheadedness. These
  effects may be worse if you take it with alcohol or certain medicines. Use
  Acetaminophen/Hydrocodone with caution. Do not drive or perform other
  possibly unsafe tasks until you know how you react to it.

• Do not drink alcohol or use
  medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while
  you are using Acetaminophen/Hydrocodone ; it may add to their effects. Ask
  your pharmacist if you have questions about which medicines may cause
  drowsiness.

• Acetaminophen/Hydrocodone may
  cause dizziness, lightheadedness, or fainting; alcohol, hot weather,
  exercise, or fever may increase these effects. To prevent them, sit up or
  stand slowly, especially in the morning. Sit or lie down at the first sign
  of any of these effects.

• Some of these products contain
  sulfites. Sulfites may cause an allergic reaction in some patients (eg,
  asthma patients). If you have ever had an allergic reaction to sulfites, ask
  your pharmacist if your product has sulfites in it.

• Acetaminophen/Hydrocodone has
  acetaminophen in it. Before you start any new medicine, check the label to
  see if it has acetaminophen in it too. If it does or if you are not sure,
  check with your doctor or pharmacist.

• Acetaminophen/Hydrocodone may
  harm your liver. Your risk may be greater if you drink alcohol while you are
  using Acetaminophen/Hydrocodone . Talk to your doctor before you take
  Acetaminophen/Hydrocodone or other fever reducers if you drink more than 3
  drinks with alcohol per day.

• Use Acetaminophen/Hydrocodone
  with caution in the ELDERLY; they may be more sensitive to its effects,
  especially possible decreased breathing and drowsiness.

• Acetaminophen/Hydrocodone should
  not be used in CHILDREN;
  safety and effectiveness in children have not been confirmed.

• PREGNANCY and BREAST-FEEDING: If
  you become pregnant, contact your doctor. You will need to discuss the
  benefits and risks of using Acetaminophen/Hydrocodone while you are
  pregnant. Acetaminophen/Hydrocodone is found in breast milk.
  Do not breast-feed while taking Acetaminophen/Hydrocodone .

When used for long periods of time or at high doses,
Acetaminophen/Hydrocodone may not work as well and may require higher doses to
obtain the same effect as when originally taken. This is known as TOLERANCE.
Talk with your doctor if Acetaminophen/Hydrocodone stops working well. Do not
take more than prescribed.

Some people who use Acetaminophen/Hydrocodone for a long time
may develop a need to continue taking it. People who take high doses are also at
risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Acetaminophen/Hydrocodone , you
may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny
nose, or sneezing; goose bumps and abnormal skin sensations; nausea;
vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling
things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Acetaminophen/Hydrocodone :

All medicines may cause side effects, but many people have
no, or minor, side effects. Check with your doctor if any
of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; difficulty breathing;
dizziness; drowsiness; flushing; lightheadedness; mental/mood changes; nausea;
vomiting.

Seek medical attention right away if any of these SEVERE
side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty
breathing; tightness in the chest; swelling of the mouth, face, lips, or
tongue); anxiety; change in the amount of urine; change or loss in hearing;
fear; interrupted breathing; mental or mood changes; unusual tiredness.