ACETAMINOPHEN AND CODEINE 300 mg; 30 mg Tablet, 30-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- This combination is used to treat mild to moderate pain — things like post-surgical pain or musculoskeletal injuries — when other options like ibuprofen or acetaminophen alone have...
- What exactly is this medication for, and is it really necessary for me to take an opioid?
- The oral solution needs to be measured very carefully, because errors between milligrams and milliliters — or mixing it up with a different strength — can be dangerous. Always use...
- How should I take the liquid version without making a dosing mistake?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 68401960MK
Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.5009 | $15.03 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 00406-0484-01 | SpecGx | 100 tablets | $0.243 | AA | Availability likely | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 13107-0059-01 | Aurolife | 100 tablets | $0.243 | AA | Availability likely | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 64380-0446-01 | Strides | 100 tablets | $0.243 | AA | Availability likely | — |
| Acetaminophen and Codeine 300 mg/1; 30 mg 65162-0033-10 | Amneal | 100 tablets | $0.243 | AA | Availability likely | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 71930-0055-12 | Eywa | 100 tablets | $0.243 | AA | Availability likely | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 49999-0060-30 | Quality | 30 tablets | — | AA | Discontinued | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 50090-4610-00 | A-S | 10 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 50090-4611-01 | A-S | 16 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 58118-4484-08 | Clinical | 30 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 60760-0581-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 60760-0938-30 | ST. | 30 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine 300 mg/1; 30 mgthis 61919-0484-30 | Direct_Rx | 30 tablets | — | AA | Discontinued | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 63187-0106-15 | Proficient | 15 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine 300 mg/1; 30 mg 63187-0491-20 | Proficient | 20 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 63187-0815-15 | Proficient | 15 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 63629-5666-01 | Bryant | 10 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 64850-0642-12 | Elite | 120 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine 300 mg/1; 30 mg 67296-1772-06 | RedPharm | 6 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 67296-2239-02 | Redpharm | 6 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 67544-0002-09 | Aphena | 9 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68071-3651-06 | NuCare | 6 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68071-3658-02 | NuCare | 20 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 68071-3798-06 | NuCare | 6 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 68071-3824-06 | NuCare | 6 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68071-4475-02 | NuCare | 12 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68071-4533-02 | NuCare | 20 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 68071-4673-02 | NuCare | 20 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 68071-5010-04 | NuCare | 4 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68788-7835-01 | Preferred | 15 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 70518-2628-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 70518-3705-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 70518-4104-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 71335-0256-00 | Bryant | 40 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine 300 mg/1; 30 mg 71335-0545-00 | Bryant | 40 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 71335-1522-00 | Bryant | 40 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 71335-1818-00 | Bryant | 40 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 71335-2916-00 | Bryant | 40 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 72162-2001-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine 300 mg/1; 30 mg 76420-0103-03 | Asclemed | 3 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 76420-0821-00 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 80425-0527-01 | Advanced | 30 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 80425-0529-01 | Advanced | 30 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 82804-0181-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 82804-0283-20 | Proficient | 20 tablets | — | AA | FDA listed | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 87441-0009-01 | Unit | 30 tablets | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61919-0484-18 | 18 TABLET in 1 BOTTLE (61919-484-18) | 2019-07-12 | Active |
| 61919-0484-30 You're viewing this | 30 TABLET in 1 BOTTLE (61919-484-30) | 2019-07-12 | Discontinued by firm |
| 61919-0484-71 | 100 TABLET in 1 BOTTLE (61919-484-71) | 2019-07-12 | Active |
| 61919-0484-90 | 90 TABLET in 1 BOTTLE (61919-484-90) | 2019-07-12 | Active |
| 61919-0484-10 | 10 TABLET in 1 BOTTLE (61919-484-10) | 2019-07-12 | Active |
You're viewing one of 5 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 61919-0484-30?
What is the difference between NDC 61919-0484-30 and NDC 61919-0484-10?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Acetaminophen and codeine phosphate tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Assess each patient’s risk prior to prescribing acetaminophen and codeine phosphate tablets, and monitor all patients regularly for the development of these behaviors and conditions (see WARNINGS). Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products (see WARNINGS). Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of acetaminophen and codeine phosphate tablets.
Monitor for respiratory depression, especially during initiation of acetaminophen and codeine phosphate tablets or following a dose increase (see WARNINGS). Accidental Ingestion Accidental ingestion of acetaminophen and codeine phosphate tablets, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate tablets (see WARNINGS). Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children Life-threatening respiratory depression and death have occurred in children who received codeine.
Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism (see WARNINGS, PRECAUTIONS; Information for Patients/Caregivers, Nursing Mothers). Acetaminophen and codeine phosphate tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see CONTRAINDICATIONS). Avoid the use of acetaminophen and codeine phosphate tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
Neonatal Opioid Withdrawal Syndrome Prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available (see WARNINGS). Interactions with Drugs Affecting Cytochrome P450 Isoenzymes The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex.
Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with acetaminophen and codeine…
🎯 Indications and Usage ▾
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) Have not provided adequate analgesia, or are not expected to provide adequate analgesia, Have not been tolerated, or are not expected to be tolerated.
⏱️ 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 th…
⛔ Contraindications ▾
Acetaminophen and codeine phosphate tablets are contraindicated for: All children younger than 12 years of age (see WARNINGS). Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS). Acetaminophen and codeine phosphate tablets are contraindicated in patients with: significant respiratory depression (see WARNINGS). acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS). concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days (see WARNINGS). known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS). hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) (see WARNINGS).
⚠️ Warnings ▾
Addiction, Abuse, and Misuse Acetaminophen and codeine phosphate tablets contain codeine. Codeine in combination with acetaminophen, is a Schedule III controlled substance. As an opioid, acetaminophen and codeine phosphate tablets expose users to the risks of addiction, abuse, and misuse (see DRUG ABUSE AND DEPENDENCE).
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed acetaminophen and codeine phosphate tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing acetaminophen and codeine phosphate tablets, and monitor all patients receiving acetaminophen and codeine phosphate tablets for the development of these behaviors and conditions.
Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as acetaminophen and codeine phosphate tablets, but use in such patients necessitates intensive counseling about the risks and proper use of acetaminophen and codeine phosphate tablets along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing acetaminophen and codeine phosphate tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug (see PRECAUTIONS, Information for Patients/Caregivers).
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
Healthcare providers are strongly encouraged to do all of the following: Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed.
The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG. Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them. Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities.
To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 800-503-0784, or log on to www.opioidanalgesicrems.com. The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.
Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management…
🤒 Adverse Reactions ▾
The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse (see WARNINGS) Life-Threatening Respiratory Depression (see WARNINGS) Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children (see WARNINGS) Neonatal Opioid Withdrawal Syndrome (see WARNINGS) Interactions with CNS Depressants (see WARNINGS) Severe Hypotension (see WARNINGS) Gastrointestinal Adverse Reactions (see WARNINGS) Seizures (see WARNINGS) Withdrawal (see WARNINGS) The following adverse reactions associated with the use of codeine were identified in postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions associated with codeine are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest. The most frequently observed adverse reactions with codeine administration include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation.
Other adverse reactions include allergic reactions, euphoria, dysphoria, abdominal pain, pruritus, rash, thrombocytopenia, and agranulocytosis. Other less frequently observed adverse reactions expected from opioid analgesics, including acetaminophen and codeine phosphate tablets: Cardiovascular System: faintness, flushing, hypotension, palpitations, syncope. Digestive System: abdominal cramps, anorexia, diarrhea, dry mouth, gastrointestinal distress, pancreatitis.
Nervous System: anxiety, drowsiness, fatigue, headache, insomnia, nervousness, shakiness, somnolence, vertigo, visual disturbances, weakness. Skin and Appendages: rash, sweating, urticarial. Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Anaphylaxis: Anaphylaxis has been reported with ingredients contained in acetaminophen and codeine phosphate tablets. Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids (see CLINICAL PHARMACOLOGY).
🆘 Overdosage ▾
Following an acute overdosage, toxicity may result from codeine or acetaminophen. Clinical Presentation Codeine Acute overdosage with codeine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Acetaminophen Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdose. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: anorexia, nausea, vomiting, diaphoresis, pallor and general malaise.
Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment of Overdose Codeine In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.
Cardiac arrest or serious arrhythmias will require advanced life-support measures. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to acetaminophen and codeine overdose, administer an opioid antagonist.
Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to codeine overdose. Because the duration of opioid reversal is expected to be less than the duration of action of codeine in acetaminophen and codeine phosphate tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
Acetaminophen Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, (NAC) should be administered as soon as possible where impending or evolving liver injury is suspected.
Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs early in the course of intoxication.
🧬 Clinical Pharmacology ▾
Mechanism of Action Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.
Pharmacodynamics Effects on the Central Nervous System Codeine produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. Codeine causes miosis, even in total darkness.
Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Effects on the Gastrointestinal Tract and Other Smooth Muscle Codeine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.
Effects on the Cardiovascular System Codeine produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans (see ADVERSE REACTIONS).
They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date (see ADVERSE REACTIONS).
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
Concentration-Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. The minimum effective analgesic concentration of codeine for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, and/or the development of analgesic tolerance (see DOSAGE AND ADMINISTRATION). Concentration-Adverse Reaction Relationships There is a relationship between increasing codeine plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.
In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions (see DOSAGE AND ADMINISTRATION). Pharmacokinetics The behavior of the individual components is described below. Codeine Codeine is rapidly absorbed from the gastrointestinal tract.
It is rapidly distribute…
📦 How Supplied / Storage and Handling ▾
Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg. It is available as a round, white to off-white tablet debossed with “2” on one side and an M within a box or logo symbol representing M within a box Bottles of 100......................................... 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 within a box or logo symbol representing M within a box Bottles of 20............................................ Bottles of 30............................................ Bottles of 50............................................
Bottles of 100......................................... Bottles of 1000....................................... Unit Dose (10 x 10)...............................
Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. It is available as a round, white to off-white tablet debossed with “4” on one side and an M within a box or logo symbol representing M within a box Bottles of 100......................................... Bottles of 500.........................................
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. 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 07/2018 MallinckrodtTM 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.
📋 Description ▾
Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: [Acetaminophen Chemical Structure] Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive.
It has the following structural formula: [Codeine Phosphate Chemical Structure] Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.
💬 Medication Guide ▾
Medication Guide Acetaminophen 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 code…