ACETAMINOPHEN AND CODEINE PHOSPHATE 300 mg; 30 mg Tablet, 1 tablet
🆔 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
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🩺 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 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 M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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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 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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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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.
8 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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💲 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 | $0.50 / 1 tablet |
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 mg 61919-0484-18 | Direct_Rx | 18 tablets | — | AA | FDA listed | — |
| 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 mgthis 76420-0821-01 | Asclemed | 1 tablet | — | 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
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 76420-0821-00 | 100 TABLET in 1 BOTTLE (76420-821-00) | 2024-07-01 | Active |
| 76420-0821-01 You're viewing this | 1 TABLET in 1 BOTTLE (76420-821-01) | 2024-07-01 | Active |
| 76420-0821-03 | 3 TABLET in 1 BOTTLE (76420-821-03) | 2024-07-01 | Active |
| 76420-0821-05 | 5 TABLET in 1 BOTTLE (76420-821-05) | 2024-07-01 | Active |
| 76420-0821-10 | 10 TABLET in 1 BOTTLE (76420-821-10) | 2024-07-01 | Active |
| 76420-0821-12 | 12 TABLET in 1 BOTTLE (76420-821-12) | 2024-07-01 | Active |
| 76420-0821-15 | 15 TABLET in 1 BOTTLE (76420-821-15) | 2024-07-01 | Active |
| 76420-0821-20 | 20 TABLET in 1 BOTTLE (76420-821-20) | 2024-07-01 | Active |
| 76420-0821-24 | 24 TABLET in 1 BOTTLE (76420-821-24) | 2025-08-17 | Active |
| 76420-0821-30 | 30 TABLET in 1 BOTTLE (76420-821-30) | 2024-07-01 | Active |
| 76420-0821-50 | 500 TABLET in 1 BOTTLE (76420-821-50) | 2024-07-01 | Active |
| 76420-0821-60 | 60 TABLET in 1 BOTTLE (76420-821-60) | 2024-07-01 | Active |
| 76420-0821-90 | 90 TABLET in 1 BOTTLE (76420-821-90) | 2024-07-01 | Active |
You're viewing the smallest of 13 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 76420-0821-01?
What is the difference between NDC 76420-0821-01 and NDC 76420-0821-03?
What NDC number is used to bill for this package of ACETAMINOPHEN AND CODEINE PHOSPHATE 300 mg; 30 mg Tablet?
🧭 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 ▾
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 cytochrome P450 (CYP) 2D6 polymorphism (see WARNINGS , PRECAUTIONS ; Information for Patients/Caregivers, Nursing Mothers). Acetaminophen and codeine phosphate tablets is 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 (see WARNINGS , PRECAUTIONS ).
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 , PRECAUTIONS ).
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes The effects of concomitant use or discontinuation of CYP3A4 inducers, CYP3A4 inhibitors, or CYP2D6 inhibitors with codeine are complex. Use of CYP3A4 indu…
🎯 Indications and Usage ▾
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 ▾
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 24–72 hours of initiating therapy and following dosage increases with acetaminophen and codeine phosphate tablets and adjust the dosage accordingly (see WARNINGS ).
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with acetaminophen and codeine phosphate tablets (see WARNINGS, Life-Threatening Respiratory Depression ; PRECAUTIONS , Information for Patients/Caregivers ). Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing regulations (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).
Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient (see WARNINGS, Addiction, Abuse, and Misuse, Life-Threatening Respiratory Depression, Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants ). Consider prescribing naloxone when the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose.
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 1000 mg 4000 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 acetamino…
⛔ Contraindications ▾
CONTRAINDICATIONS Acetaminophen and codeine phosphate tablets are contraindicated for: · All children younger than 12 years of age (see WARNINGS ) · Post-operative 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 ingredients (e.g., anaphylaxis) (see WARNINGS ).
⚠️ 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.
Consider prescribing naloxone for the emergency treatment of opioid overdose (see WARNINGS , Life-Threatening Respiratory Depression ; DOSAGE AND ADMINISTRATION , Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose ). 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 Dep…
🤒 Adverse Reactions ▾
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 have been identified during post-approval use of acetaminophen and codeine phosphate tablets.
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: fixed eruption, 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 ).
🔄 Drug Interactions ▾
Drug Interactions Anticoagulants Chronic oral acetaminophen use at a dose of 4000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. As no studies have been performed evaluating the short term use of acetaminophen and codeine phosphate tablets in patients on oral anticoagulants, more frequent assessment of INR may be appropriate in such circumstances. CYP2D6 Inhibitors Codeine is metabolized by CYP2D6 to form morphine.
The concomitant use of acetaminophen and codeine phosphate tablets and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced analgesic efficacy or symptoms of opioid withdrawal, particularly when an inhibitor is added after a stable dose of acetaminophen and codeine phosphate tablets is achieved (see CLINICAL PHARMACOLOGY ). After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the codeine plasma concentration will decrease but the active metabolite morphine plasma concentration will increase, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression (see CLINICAL PHARMACOLOGY ).
If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of acetaminophen and codeine phosphate tablets and monitor patients closely at frequent intervals. If concomitant use with CYP2D6 inhibitors is necessary, follow the patient for reduced efficacy or signs and symptoms of opioid withdrawal and consider increasing the dosage of acetaminophen and codeine phosphate tablets as needed. After stopping use of a CYP2D6 inhibitor, consider reducing the dosage of acetaminophen and codeine phosphate tablets and monitor the patient for signs and symptoms of respiratory depression or sedation.
CYP3A4 Inhibitors The concomitant use of acetaminophen and codeine phosphate tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations , with subsequently greater metabolism by CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of acetaminophen and codeine phosphate tablets is achieved (see WARNINGS ).
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metabolism via CYP2D6 with resultant lower morphine levels (see CLINICAL PHARMACOLOGY ), resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine. If concomitant use of CYP3A4 inhibitor is necessary, consider dosage reduction of acetaminophen and codeine phosphate tablets until stable drug effects are achieved.
Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the acetaminophen and codeine phosphate tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
CYP3A4 Inducers The concomitant use of acetaminophen and codeine phosphate tablets and CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) can result in lower codeine levels, greater norcodeine levels, and less metabolism via CYP2D6 with resultant lower morphine levels (see CLINICAL PHARMACOLOGY ), resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence (see WARNINGS ). After stopping a CYP3A4 inducer, as the effects of the inducer decline…
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Codeine may increase serum amylase levels. Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Codeine A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100 mg/kg subcutaneous dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring.
There are no adequate and well-controlled studies in pregnant women. Acetaminophen and codeine phosphate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly (see WARNINGS ).
🧒 Pediatric Use ▾
Pediatric Use The safety and effectiveness of acetaminophen and codeine phosphate tablets with Codeine in pediatric patients below the age of 18 have not been established. Life-threatening respiratory depression and death have occurred in children who received codeine (see WARNINGS ). In most of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for CYP2D6 or high morphine concentrations).
Children with sleep apnea may be particularly sensitive to the respiratory depressant effects of codeine. Because of the risk of life-threatening respiratory depression and death: · Acetaminophen and codeine phosphate tablets are contraindicated for all children younger than 12 years of age (see CONTRAINDICATIONS ). · Acetaminophen and codeine phosphate tablets are contraindicated for post-operative management in pediatric patients 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 unless the benefits outweigh the risks.
Risk factors include conditions associated with hypoventilation, such as post-operative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression (see WARNINGS ).
🧓 Geriatric Use ▾
Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to acetaminophen and codeine phosphate tablets. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.
Titrate the dosage of acetaminophen and codeine phosphate tablets slowly in geriatric patients and monitor closely for signs of central nervous system depression (see WARNINGS ). These drugs are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
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. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to acetaminophen and codeine phosphate tablets overdose, administer an opioid antagonist.
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 ▾
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…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg contain acetaminophen 300 mg and codeine phosphate 30 mg. The tablets are white colored, round flat-faced beveled edge, debossed one side with W242. Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg are supplied as follows: Bottles of 1 - NDC 76420-821-01 (repackaged from NDC 71930-055-XX) Bottles of 3 - NDC 76420-821-03 (repackaged from NDC 71930-055-XX) Bottles of 5 - NDC 76420-821-05 (repackaged from NDC 71930-055-XX) Bottles of 10 - NDC 76420-821-10 (repackaged from NDC 71930-055-XX) Bottles of 12 - NDC 76420-821-12 (repackaged from NDC 71930-055-XX) Bottles of 15 - NDC 76420-821-15 (repackaged from NDC 71930-055-XX) Bottles of 20 - NDC 76420-821-20 (repackaged from NDC 71930-055-XX) Bottles of 24 - NDC 76420-821-24 (repackaged from NDC 71930-055-XX) Bottles of 30 - NDC 76420-821-30 (repackaged from NDC 71930-055-XX) Bottles of 60 - NDC 76420-821-60 (repackaged from NDC 71930-055-XX) Bottles of 90 - NDC 76420-821-90 (repackaged from NDC 71930-055-XX) Bottles of 100 - NDC 76420-821-00 (relabeled from NDC 71930-055-12) Bottles of 500 - NDC 76420-821-50 (relabeled from NDC 71930-055-52) Store Acetaminophen and Codeine Phosphate Tablets, USP 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.
Store acetaminophen and codeine phosphate tablets securely and dispose of properly (see PRECAUTIONS , Information for Patients ). Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501
📋 Description ▾
DESCRIPTION Acetaminophen and Codeine Phosphate Tablets, USP 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: C 8 H 9 NO 2 M.W.
151.16 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: C 18 H 21 NO 3 H 3 PO 4 ½H 2 O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and stearic acid. codeine-01 codeine-03
💬 Information for Patients ▾
Information for Patients/Caregivers Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal: Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store acetaminophen and codeine phosphate tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see WARNINGS , DRUG ABUSE AND DEPENDENCE ]. Inform patients that leaving acetaminophen and codeine phosphate tablets unsecured can pose a deadly risk to others in the home.
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Inform patients that medicine take-back options are the preferred way to safely dispose of most types of unneeded medicines. If no take back programs or DEA-registered collectors are available, instruct patients to dispose of acetaminophen and codeine phosphate tablets by following these four steps: • Mix acetaminophen and codeine phosphate tablets (do not crush) with an unpalatable substance such as dirt, cat litter, or used coffee grounds; • Place the mixture in a container such as a sealed plastic bag; • Throw the container in the household trash; • Delete all personal information on the prescription label of the empty bottle Inform patients that they can visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
Addiction, Abuse and Misuse Inform patients that the use of acetaminophen and codeine phosphate tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death (see WARNINGS ). Instruct patients not to share acetaminophen and codeine phosphate tablets with others and to take steps to protect acetaminophen and codeine phosphate tablets from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting acetaminophen and codeine phosphate tablets or when the dosage is increased, and that it can occur even at recommended dosages.
Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose (see WARNINGS , Life Threatening Respiratory Depression ). Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with acetaminophen and codeine phosphate tablets.
Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) (see WARNINGS , Life-Threatening Respiratory Depression ; DOSAGE AND ADMINISTRATION ). Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered (see OVERDOSAGE ).
If naloxone is prescribed, also advise patients and caregivers: • How to treat with naloxone in the event of an opioid overdose • To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency • To read the Patient Information (or other educational material) that will come with their naloxone. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in res…
💬 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 or call 911 right away if you take too much 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. · Taking acetaminophen and codeine phosphate 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. Selling or giving away acetaminophen and codeine phosphate tablets is against the law. · Store acetaminophen and codeine phosphate tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. 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, opioid overdose, 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. · 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 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…