ACETAMINOPHEN AND CODEINE PHOSPHATE (Page 5 of 6)

DOSAGE AND ADMINISTRATION

Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse (see WARNINGS).

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with acetaminophen and codeine phosphate tablets and adjust the dosage accordingly (see WARNINGS).

Initial Dosage

Initiating Treatment with Acetaminophen and Codeine Phosphate Tablets

Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg are associated with an increased incidence of adverse reactions and are not associated with greater efficacy.

The usual adult dosage is:

Acetaminophen and Codeine Phosphate Tablets (codeine 15 mg and acetaminophen 300 mg): Take 1 to 2 tablets every 4 hours as needed for pain.

Acetaminophen and Codeine Phosphate Tablets (codeine 30 mg and acetaminophen 300 mg): Take 1 to 2 tablets every 4 hours as needed for pain.

Acetaminophen and Codeine Phosphate Tablets (codeine 60 mg and acetaminophen 300 mg): Take one tablet every 4 hours as needed for pain.

	Single Doses (Range)	Maximum 24-Hour Dose
Codeine Phosphate	15 mg to 60 mg	360 mg
Acetaminophen	300 mg to 1,000 mg	4,000 mg

The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours, based upon the above dosage guidance. This information should be conveyed in the prescription.

Conversion from Other Opioids to Acetaminophen and Codeine Phosphate Tablets

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of acetaminophen and codeine phosphate tablets. It is safer to underestimate a patient’s 24-hour acetaminophen and codeine phosphate tablets dosage than to overestimate the 24-hour acetaminophen and codeine phosphate tablets dosage and manage an adverse reaction due to overdose.

Titration and Maintenance of Therapy

Individually titrate acetaminophen and codeine phosphate tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving acetaminophen and codeine phosphate tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse (see WARNINGS). Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the acetaminophen and codeine phosphate tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of Acetaminophen and Codeine Phosphate Tablets

When a patient who has been taking acetaminophen and codeine phosphate tablets regularly and may be physically dependent no longer requires therapy with acetaminophen and codeine phosphate tablets, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue acetaminophen and codeine phosphate tablets in a physically-dependent patient (see WARNINGS and DRUG ABUSE AND DEPENDENCE).

HOW SUPPLIED

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg. It is available as a round, white to off-white tablet debossed with “3” on one side and an M on the other side.

Store acetaminophen and codeine phosphate tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container as defined in the USP.

Repackaged by: Aidarex Pharmaceuticals, LLC, Corona, CA 92880

Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and M are trademarks of a Mallinckrodt company.
© 2018 Mallinckrodt.

SpecGx LLC
Webster Groves, MO 63119 USA

Rev 02/2018

Mallinckrodt^TM Pharmaceuticals

An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20A08.pdf or by calling 1-800-778-7898 for alternate delivery options.

Medication GuideAcetaminophen and Codeine Phosphate Tablets USP, CIII(a seet’ a min’ oh fen and koe’ deen fos’ fate)

Acetaminophen and codeine phosphate tablets are: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage mild to moderate pain, 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.

Important information about acetaminophen and codeine phosphate tablets: Get emergency help right away if you take too many acetaminophen and codeine phosphate tablets (overdose). When you first start taking acetaminophen and codeine phosphate tablets, 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. Taking acetaminophen and codeine tablets 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 acetaminophen and codeine phosphate tablets. They could die from taking it. Store acetaminophen and codeine phosphate tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away acetaminophen and codeine phosphate tablets is against the law.

Important Information Guiding Use in Pediatric Patients: Do not give acetaminophen and codeine phosphate tablets to a child younger than 12 years of age. Do not give acetaminophen and codeine phosphate tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids. Avoid giving acetaminophen and codeine phosphate tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

Do not take acetaminophen and codeine phosphate tablets if you have: severe asthma, trouble breathing, or other lung problems. a bowel blockage or narrowing of the stomach or intestines. previously had an allergic reaction to codeine or acetaminophen.

Before taking acetaminophen and codeine phosphate 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, or mental health problems Have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines. Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. breastfeeding. Not recommended; may harm your baby. taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking acetaminophen and codeine phosphate tablets with certain other medicines can cause serious side effects that could lead to death.

When taking acetaminophen and codeine phosphate tablets: Do not change your dose. Take acetaminophen and codeine phosphate tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. Take your prescribed dose every 4 hours as needed. Do not take more than your prescribed dose. If you miss a dose, take your next dose when needed. Call your healthcare provider if the dose you are taking does not control your pain. If you have been taking acetaminophen and codeine phosphate tablets regularly, do not stop taking acetaminophen and codeine phosphate tablets without talking to your healthcare provider. After you stop taking acetaminophen and codeine phosphate tablets, dispose of any unused tablets in accordance with local state guidelines and/or regulations.

While taking acetaminophen and codeine phosphate tablets DO NOT: Drive or operate heavy machinery, until you know how acetaminophen and codeine phosphate tablets affect you. Acetaminophen and codeine phosphate 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 acetaminophen and codeine phosphate tablets may cause you to overdose and die.

The possible side effects of acetaminophen and codeine phosphate 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 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 acetaminophen and codeine phosphate 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.Manufactured by: SpecGx LLC, Webster Groves, MO 63119 USA, www.mallinckrodt.com or call 1-800-778-7898 Repackaged by: Aidarex Pharmaceuticals, LLC, Corona, CA 92880

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Mallinckrodt^TM

Issued: 02/2018
MG20A08