Acetaminophen; Hydrocodone tablets or capsules

What is this medicine?

ACETAMINOPHEN; HYDROCODONE (a set a MEE noe fen; hye droe KOE done) is a pain reliever. It is used to treat mild to moderate pain.

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What should I tell my health care provider before I take this medicine?

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They need to know if you have any of these conditions:
-brain tumor
-Crohn's disease, inflammatory bowel disease, or ulcerative colitis
-drink more than 3 alcohol-containing drinks per day
-drug abuse or addiction
-head injury
-heart or circulation problems
-kidney disease or problems going to the bathroom
-liver disease
-lung disease, asthma, or breathing problems
-an unusual or allergic reaction to acetaminophen, hydrocodone, other opioid analgesics, other medicines, foods, dyes, or preservatives
-pregnant or trying to get pregnant
-breast-feeding

How should I use this medicine?

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Take this medicine by mouth. Swallow it with a full glass of water. Follow the directions on the prescription label. If the medicine upsets your stomach, take the medicine with food or milk. Do not take more than you are told to take.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What if I miss a dose?

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If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

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-alcohol
-antihistamines
-isoniazid
-medicines for depression, anxiety, or psychotic disturbances
-medicines for sleep
-muscle relaxants
-naltrexone
-narcotic medicines (opiates) for pain
-phenobarbital
-ritonavir
-tramadol

What should I watch for while using this medicine?

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Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy when you first start taking the medicine or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medicine affects you. Stand or sit up slowly.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

The medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

Too much acetaminophen can be very dangerous. Do not take Tylenol (acetaminophen) or medicines that contain acetaminophen with this medicine. Many non-prescription medicines contain acetaminophen. Always read the labels carefully.

What side effects may I notice from receiving this medicine?

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Side effects that you should report to your doctor or health care professional as soon as possible:
-allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
-breathing problems
-confusion
-feeling faint or lightheaded, falls
-stomach pain
-yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
-nausea, vomiting
-stomach upset

Where should I keep my medicine?

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Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed.

Throw away any unused medicine after the expiration date. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

Information on use before, during and after pregnancy.

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FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.