Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet, 15-count — NDC 63187-815-15 (Billing 63187-0815-15)
This is a package of 15 tablets of Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet from Proficient Rx LP, marketed since Jan 2017 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.
NDC database record
One package, one record: these facts belong to NDC 63187-815-15 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63187 labeler · 815 product · 15 package
- Package marketed since
- May 28, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 15 EA per package
- Barcode (UPC)
- 0363187815158
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 004165
- GCN: 70134
- GPI-14 (Medi-Span): 65991002050315
- HICL (First Databank): 001717
- AHFS class code: 28:08.08.00
- RxCUI (RxNorm): 993781
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
The combination of acetaminophen and codeine is used to relieve pain. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body. Codeine belongs to a class of medications called opiate (narcotic) analgesics. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain.
Read the full MedlinePlus article ↗- It treats mild to moderate pain when you need an opioid and other pain relievers have not worked or were not tolerated. It is not meant for long-term use unless your pain stays sev...
- Take it by mouth exactly as prescribed, usually as needed for pain. Your prescriber aims for the lowest dose for the shortest time. If you have the liquid, use an oral syringe or c...
- Drowsiness, dizziness, nausea, vomiting, sweating, and constipation are common. Call for help right away if you have slow or shallow breathing, extreme sleepiness, fainting, or sig...
- No, not without checking with me or your doctor first. Alcohol, benzodiazepines, and other sedating drugs can cause dangerous sleepiness, slowed breathing, coma, and death.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $7.51 / 15 tablets |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 63187-0815-15 You're viewing this Main listing | 15 TABLET in 1 BOTTLE | 2020-05-28 | — | Active |
| 63187-0815-20 63187-815-20 | 20 TABLET in 1 BOTTLE | 2017-02-01 | — | Active |
| 63187-0815-30 63187-815-30 | 30 TABLET in 1 BOTTLE | 2017-02-01 | — | Active |
| 63187-0815-60 63187-815-60 | 60 TABLET in 1 BOTTLE | 2017-02-01 | — | Active |
You're viewing the smallest of 4 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 63187-0815-20?
What NDC number is used to bill for this package of Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet?
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 | $0.256 | AA | Availability likely | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 13107-0059-01 | Aurolife | 100 tablets | $0.256 | AA | Availability likely | — |
| Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 64380-0446-01 | Strides | 100 tablets | $0.256 | AA | Availability likely | — |
| Acetaminophen and Codeine 300 mg/1; 30 mg 65162-0033-10 | Amneal | 100 tablets | $0.256 | AA | Availability likely | — |
| Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 71930-0055-12 | Eywa | 100 tablets | $0.256 | 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 mgthis 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?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Proficient Rx LP labeler code 63187
- Nortriptyline Hydrochloride 75 mg Capsule NDC 63187-809-00
- Gabapentin 300 mg Capsule NDC 63187-810-00
- Glipizide 10 mg Tablet NDC 63187-811-30
- Cyclobenzaprine Hydrochloride 10 mg Tablet, Film Coated NDC 63187-812-07
- Sildenafil 20 mg Tablet, Film Coated NDC 63187-813-10
- Lovastatin 10 mg Tablet NDC 63187-814-30
- Ramipril 10 mg Capsule NDC 63187-816-30
- Eszopiclone 1 mg Tablet, Film Coated NDC 63187-817-30
- Bupropion Hydrochloride 300 mg Tablet, Extended Release NDC 63187-819-30
- Omeprazole 20 mg Capsule, Delayed Release NDC 63187-820-06
- Lisinopril 10 mg Tablet NDC 63187-821-30
- Oxycodone and Acetaminophen 10 mg; 325 mg Tablet NDC 63187-823-15
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
BOXED WARNING WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE; HEPATOTOXICITY; CYTOCHROME P450 2D6 INTERACTION; 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 ]. 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 even one dose of acetaminophen and codeine phosphate tablets, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate tablets [see WARNINGS ]. 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 ]. Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism [see WARNINGS , PRECAUTIONS ; Information for Patients/Caregivers, Nursing mothers ].
Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [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 Phosphate Tablets requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Cytochrome P450 3A4 Interaction The concomitant use of Acetaminophen and Codeine Phosphate Tablets with all cytochrome P450 3A4 inhibitors or discontinuation of a cytochrome P450 3A4 inducer may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome P450 2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.
The concomitant use of Acetaminophen and Codeine Phosphate Tablets with all cytochrome P450 3A4 inducers or discontinuation of a cytochrome P450 3A4 inhibitor may result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels. This may be associated with a decrease in efficacy, and in some patients, may result in signs and symptoms of opioid withdrawal. Follow patients receiving Acetaminophen and Codeine Phosphate Tablets and any CYP3A4 inhibitor or inducer for signs and symptoms that may reflect opioid toxicity and opioid withd… [Excerpted — this section continues on DailyMed.]
🎯 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 Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Important Dosage and Administration Instructions 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 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. The usual dose of codeine phosphate in children is 0.5 mg/kg.
Doses may be repeated up to every 4 hours. 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. Initiating Treatment with Acetaminophen and Codeine Phosphate Tablets 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.
It should be kept in mind, however, 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 fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
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 so… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Acetaminophen and codeine phosphate tablets are contraindicated in patients with: • Patients with significant respiratory depression [see WARNINGS]. • Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS]. • Postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see WARNINGS]. • Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS]. • Patients with hypersensitivity to codeine, acetaminophen, or any of the formulation excipients.
(e.g., anaphylaxis) [see WARNINGS]. • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days.
⚠️ Warnings ▾
WARNINGS Addiction, Abuse, and Misuse An acetaminophen and codeine phosphate tablet contains codeine, a Schedule II controlled substance. As an opioid, acetaminophen and codeine phosphate tablets exposes 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 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]. 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.
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 of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see OVERDOSAGE ].
Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of acetaminophen and codeine phosphate tablets the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with and following dosage increases of acetaminophen and codeine phosphate tablets.
To reduce the risk of respiratory depression, proper dosing and titration of acetaminophen and codeine phosphate tablets are essential [see DOSAGE AND ADMINISTRATION ]. Overestimating the acetaminophen and codeine phosphate tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose. Accidental ingestion of acetaminophen and codeine phosphate tablets, especially by children, can result in respiratory depression and death due to an overdose of codeine.
Neonatal Opioid Withdrawal Syndrome Prolonged use ofacetaminophen and codeine phosphate tabletsduring pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly.
Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate trea… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of Acetaminophen and Codeine Phosphate Tablets. Because these reactions are 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. • Addiction, Abuse, and Misuse [see WARNINGS ] • Life-Threatening Respiratory Depression [see WARNINGS ] • Neonatal Opioid Withdrawal Syndrome [see WARNINGS] • Ultra-rapid Metabolizers of Codeine [see WARNINGS ] • Interactions with CNS Depressants [see WARNINGS ] • Severe Hypotension [see WARNINGS ] • Gastrointestinal Adverse Reactions [see WARNINGS ] • Seizures [see WARNINGS ] • Withdrawal [see WARNINGS ] 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, constipation, abdominal pain, pruritus, rash, thrombocytopenia, and agranulocytosis. 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 ▾
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 acetminophen. 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 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 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 phosphate tablets overdose, administer an opioid antagonist.
In patients who are physically dependent on any opioid agonist including Acetaminophen and Codeine Phosphate Tablets, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.
Because the duration of opioid reversal is expected to be less than the duration of action of acetaminophen and codeine phosphate in acetaminophen and codeine phosphate tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. 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. 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 readily absorbed from the gastrointestinal tract.
It… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Acetaminophen and codeine phosphate tablets, USP are supplied as follows: 300 mg/30 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U36” on one side and plain on the other side. Bottles of 15 NDC 63187-815-15 Bottles of 20 NDC 63187-815-20 Bottles of 30 NDC 63187-815-30 Bottles of 60 NDC 63187-815-60 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep this and all medication out of the reach of children. Protect from moisture.
Dispense in a tight, light-resistant container as described in the USP. PROTECT FROM LIGHT Dispense with Medication Guide availableat www.aurobindousa.com/product-medication-guides Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Repackaged by: Proficient Rx LP.
Thousand Oaks, CA 91320 Revised: 12/2016 LM 2126
📋 Description ▾
DESCRIPTION Acetaminophen and codeine phosphate tablets, USP are 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: 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: Each tablet contains: Acetaminophen............................300 mg Codeine Phosphate........................15 mg (Warning: May be habit forming) OR Acetaminophen............................300 mg Codeine Phosphate........................30 mg (Warning: May be habit forming) OR Acetaminophen............................300 mg Codeine Phosphate........................60 mg (Warning: May be habit forming) In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and stearic acid. chemical structure chemical structure
💬 Medication Guide ▾
Medication Guide MEDICATION GUIDE Acetaminophenand Codeine Phosphate Tablets, USP CIII ass-cet-ah-MEE-noe-fenwith KOE-deen FOSS-fate Acetaminophen and Codeine PhosphateTablets 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 codeinephosphate tablets: • Get emergency help 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. • Acetaminophen and Codeine Phosphate Tablets can cause severe drowsiness, breathing problems (respiratory depression), coma and death when taken with benzodiazepines or other medicines that depress consciousness. • 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 are against the law.
Do not take Acetaminophen and Codeine Phosphate Tablets ifyou 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 phosphatetablets, tell your healthcare providerif 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.
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. acetaminophen and codeine phosphate passes into breast milk and may harm your baby. • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking acetaminophen and codeine phosphate tablets with certain other medicines can cause serious side effects that could lead to death.
When taking Acetaminophen and Codeine Phosphate Tablets: • Do not change your dose. Take Acetaminophen and Codeine Phosphate Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. •Take your prescribed dose every 4 hours as needed.
Do not take more than your prescribed dose. If you miss a dose, take your next dose when needed. •Call your healthcare provider if the dose you are taking does not control your pain. •If you have been taking Acetaminophen and Codeine Phosphate Tablets regularly, do not stop taking Acetaminophen and Codeine Phosphate Tablets without talking to your healthcare provider. •After you stop taking Acetaminophen and Codeine Phosphate Tablets, to properly dispose of the Acetaminophen and Codeine Phosphate Tablets flush it down the toilet or dispose of in accordance with local state guidelines and/or regulations.
While taking acetaminophen and codeine phosphate tabletsDO NOT: • Drive or operate heavy machinery, until you know howacetaminophen and codeine phosphate tablets affects you. Acetaminophen and codeine phosphate tablets can make you sleepy, dizzy, or lightheaded. • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products con… [Excerpted — this section continues on DailyMed.]
⚠️ Precautions ▾
PRECAUTIONS Risks of Driving and Operating Machinery Acetaminophen and Codeine Phosphate Tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Acetaminophen and Codeine Phosphate Tablets and know how they will react to the medication [see PRECAUTIONS ; Information for Patients/Caregivers ] . Information for Patients/Caregivers 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 tabletsfrom 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 [see WARNINGS ]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ]. Instruct patients to take steps to store acetaminophen and codeine phosphate tablets securely Advise patients to properly dispose of the Acetaminophen and Codeine Phosphate Tablets in accordance with local state guidelines and/or regulations. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if acetaminophen and codeine phosphate tablets is used with benzodiazepines or other CNS depressants,including alcohol, and not to use these concomitantly unless supervised by a health care provider [see WARNINGS , PRECAUTIONS ; Drug Interactions] .
Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications [see PRECAUTIONS; Drug Interactions].
MAOI Interaction Inform patients not to take Acetaminophen and Codeine Phosphate Tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking [TRADENAME] [see W&P or DI]. Adrenal Insufficiency Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition.
Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see WARNINGS ]. Important Administration Instructions Instruct patients how to properly take Acetaminophen and Codeine Phosphate Tablets [see DOSAGE and ADMINISTRATION ].
Maximum Daily Dose of Acetaminophen Inform patients not to take more than 4,000 milligrams of acetaminophen per day. Advise patients to call their healthcare provider if they have taken more than the recommended dose. Hypotension Inform patients that Acetaminophen and Codeine Phosphate Tablets may cause orthostatic hypotension and syncope.
Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see WARNINGS; Hypotension]. Anaphylaxis Inform patients that… [Excerpted — this section continues on DailyMed.]
🔒 Drug Abuse and Dependence ▾
DRUG ABUSE AND DEPENDENCE Controlled Substance Acetaminophen and codeine phosphate tablet contains acetaminophen and codeine phosphate, a Schedule CII controlled substance. Abuse Acetaminophen and codeine phosphate tablet contains codeine, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydrormorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Acetaminophen and Codeine Phosphate Tablets can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ] .
All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful,or potentially harmful,consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug-seeking” behavior is very common in persons with substance use disorders.
Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating health care provider(s). “Doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.
Acetaminophen and codeine phosphate tablets, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Risks Specific to Abuse of Acetaminophen and Codeine Phosphate Tablets Acetaminophen and Codeine Phosphate Tablets is for oral use only. Abuse of Acetaminophen and Codeine Phosphate Tablets poses a risk of overdose and death. The risk is increased with concurrent use of Acetaminophen and Codeine Phosphate Tablets with alcohol and other central nervous system depressants.
Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Dependence Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors).
Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesi… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 300 mg/30 mg (15 Tablet Bottle) NDC 63187-815-15 Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg CIII Rx only 15 Tablets 63187-815-15
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 |
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| Product & package description | ✓ Available |
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| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
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| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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. |