Hydrocodone and acetaminophen

What is hydrocodone and acetaminophen?

Hydrocodone and acetaminophen tablets and oral solution are:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

What is the most important information I should know about hydrocodone and acetaminophen?

• Get emergency help or call 911 right away if you take too many hydrocodone and acetaminophen (overdose). When you first start taking this medication, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
• Taking hydrocodone and acetaminophen with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your hydrocodone and acetaminophen. They could die from taking it. Selling or giving away this medication is against the law.
• Store hydrocodone and acetaminophen tablets and oral solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Who should not take hydrocodone and acetaminophen?

Do not take hydrocodone and acetaminophen if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.
• known hypersensitivity to hydrocodone or acetaminophen, or any ingredient in the formulation of hydrocodone and acetaminophen that you take.

What should I tell my healthcare provider before taking hydrocodone and acetaminophen?

Before taking hydrocodone and acetaminophen tablets, tell your healthcare provider if you have a history of:

• head injury, seizures
• liver, kidney, thyroid problems
• problems urinating
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of hydrocodone and acetaminophen during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Hydrocodone and acetaminophen passes into breast milk and may harm your baby.
• living in a household where there are small children or someone who has abused street or prescription drugs
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydrocodone and acetaminophen with certain other medicines can cause serious side effects that could lead to death.

How should I take hydrocodone and acetaminophen?

When taking hydrocodone and acetaminophen:

• Do not change your dose. Take hydrocodone and acetaminophen exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose of your tablets or oral solution (see table below) every four to six hours as needed for pain. If you are taking hydrocodone and acetaminophen oral solution always use a calibrated measuring device to correctly measure your dose. A household teaspoon or tablespoon should not be used and could lead to overdose.
• Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking hydrocodone and acetaminophen regularly, do not stop taking it without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused hydrocodone and acetaminophen tablets by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit WWW.FDA.GOV/DRUGDISPOSAL for additional information on disposal of unused medicines.

Hydrocodone and acetaminophen oral solution dosing

^{*The usual adult dosage is one tablespoonful (15 mL) every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablespoonfuls.}

What should I avoid while taking hydrocodone and acetaminophen?

While taking hydrocodone and acetaminophen tablets DO NOT:

• Drive or operate heavy machinery, until you know how hydrocodone and acetaminophen tablets affect you. Hydrocodone and acetaminophen tablets can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with hydrocodone and acetaminophen tablets may cause you to overdose and die.

What are the possible side effects of hydrocodone and acetaminophen?

The possible side effects of hydrocodone and acetaminophen tablets:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of hydrocodone and acetaminophen tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

How should I store hydrocodone and acetaminophen?

• Tablets and oral solution - store at 20° to 25°C (68° to 77°F)
• Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure
• Store securely and dispose of properly
• Keep out of sight and reach of children

What are the ingredients in hydrocodone and acetaminophen?

Active ingredients: acetaminophen and hydrocodone bitartrate

Inactive ingredients:

Different generic formulations of hydrocodone and acetaminophen tablets and oral solution have been approved. Inactive ingredients may vary depending on the manufacturer. Refer to the product label for the formulation you take for a full list of inactive ingredients in that particular formulation.

Tablets - Anexsia 5/325 and Anexsia 7.5/325 - manufactured by SpecGX: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid.

Oral solution - Pharmaceutical Associates: alcohol, edetate disodium, glycerin, methylparaben, propylene glycol, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow No. 10 as coloring and natural and artificial flavoring.

Oral solution - TriRx Huntsville Pharmaceutical Services: alcohol, citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.

Oral solution - VistaPharm: alcohol, citric acid anhydrous, ethyl maltol, glycerin, methylparaben (preservative), propylene glycol, propylparaben (preservative), purified water, saccharin sodium, sodium citrate dihydrate, sorbitol solution, sucrose, FD&C Red #40 as coloring and artificial wild cherry as flavoring.

Oral solution - American Health Packing: ethyl alcohol USP (190 Proof), citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.