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 This medicine contains Acetaminophen and Hydrocodone 325 mg / 5 mg. This drug combination is used to relieve moderate to moderately severe pain and belongs to the drug class narcotic analgesic combinations.

Acetaminophen/hydrocodone is a combination of two different pain-relief medicines with two different mechanisms of action. Acetaminophen is used to relieve pain and reduce fever in patients, while hydrocodone belongs to a group of medicines called narcotic analgesics (pain medicines). Acetaminophen does not cause addiction but when taken in large doses, may harm the liver and could cause fatal side effects. Hydrocodone works on the central nervous system to stop pain, and stop or prevent cough. It can be habit-forming when used for a long time and could cause mental or physical dependence. Mental dependence (addiction) may not occur if this medicine is used for treatment. Physical dependence results when there is a sudden withdrawal from taking this medicine but may be prevented by tapering the dosage (with doctor’s advice) before the treatment is completely stopped.

This is a prescription medicine and is not available for use in children 6 years old and below.

Side Effects

In general, seniors or children and people with medical conditions like liver or kidney problems, heart disease, diabetes, and seizures, or people who are taking other medications are at more risk of developing side effects.

Anxiety, dizziness, drowsiness, some nausea and vomiting, constipation, upset stomach, headache, mood/behavior changes, blurry vision, ringing of the ears, and dry mouth may occur. Consult your doctor if symptoms persist or if you feel any other symptoms that may be unusual or bothersome.

Diet must be rich in fiber and water intake must be 6 to 8 full glasses daily with exercise to prevent constipation. Avoid use of laxative and stool softener while taking this medication.

To prevent dizziness and lightheadedness, get up slowly from sitting or lying position.

This medicine may or may not be taken with food. Take with food if you are feeling nauseous or lie down 1 to 2 hours with little head movement.

Ask your doctor for other ways to minimize side effects of this medication.

Immediately call for emergency help if you experience breathing problems, lightheadedness, confusion, seizure, urinary problems, nausea, stomach pain, loss of appetite, itching, and yellowing of the eyes and skin.

It is rare that an allergic reaction occurs; however, get emergency medical help if you have hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When this medication is used for a long time, it may not work as well. Talk with your doctor if the pain doesn’t go away or if the medication stops working or if you feel you may be addicted to the drug. Some other symptoms not listed above may be experienced, consult your doctor right away.

Precautions

 Allergies

• Inform the doctor if you are allergic to this medicine or medicines with similar content.
• Tell the doctor if you have allergies to other substances.

Pediatric

• Use with caution in children for risk of slow/shallow breathing.
• This medicine is not intended to for use of children 6 years old and below.

Geriatric

• Seniors are at risk for falls, accidents, and slow/shallow breathing. This medicine causes confusion, dizziness, and drowsiness.
• Use with caution especially in elderly with certain medical conditions and taking other medications.

Pregnancy and Lactation

• Acetaminophen and hydrocodone can be dangerous to the unborn child. This medicine can also cause breathing problems and addiction or withdrawal symptoms among newborn babies.
• Discuss with your doctor if you are going to take this medicine while breastfeeding. This medicine passes through breast milk and may harm the baby.
• Inform the doctor if you are pregnant, planning to get pregnant or may be pregnant while taking this medicine.

Drug Interactions

• It is important for your treating physician to know your medical history and the medicines you are taking to avoid toxic effects when combined with other medications.
• Excessive doses of acetaminophen can cause liver damage/injury.
• Inform the doctor/dentist if you are going to undergo other treatments, surgery, or dental surgery.

Missed Dose/Withdrawal Symptoms/ Overdose

• Take the missed dose as soon as you remember. Do not take an extra dose and skip the schedule if it is almost time for the next dose.
• Do not use this medicine regularly or in higher doses without your doctor’s advice. Withdrawal symptoms may occur such as restlessness, watering eyes, runny nose, nausea, sweating, and muscle aches.
• Call the doctor in case of overdose. Symptoms include slow/shallow breathing, nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, slow heartbeat, yellowing eyes/skin, dark urine, and coma.

Storage

Store in a closed container, away from moisture, heat, and direct sunlight.

Keep out of reach of children and pets.

Store in a safe place away from others.

Do not keep outdated medicine or medicines no longer needed. Ask your healthcare professional how to properly dispose unused medicines.

Disclaimer:

This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.

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