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Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet, 180-count — NDC 67544-0002-80 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet, 180-count — NDC 67544-002-80 (Billing 67544-0002-80)

by Aphena Pharma Solutions - Tennessee, LLC · 180 TABLET in 1 BOTTLE, PLASTIC

This is a package of 180 tablets of Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet from Aphena Pharma Solutions - Tennessee, LLC, marketed since Jul 2011 and currently FDA-listed.

NDC 67544-0002-80
🏷️ FDA NDC (as labeled) 67544-002-80 billing pads the product segment with a zero
This package
Contains180-count Pack sizes19 compare ↓
Also priced by: Part D plans $0.5009/unit — full pricing hub ↓
Product page 67544-0002-09 Also comes in: 9 tablets 67544-002-09 15 tablets 67544-002-15 20 tablets 67544-002-20 30 tablets 67544-002-30 40 tablets 67544-002-40 45 tablets 67544-002-45 50 tablets 67544-002-50 56 tablets 67544-002-46 60 tablets 67544-002-53 75 tablets 67544-002-55 84 tablets 67544-002-54 90 tablets 67544-002-60 112 tablets 67544-002-72 120 tablets 67544-002-70 150 tablets 67544-002-75 200 tablets 67544-002-85 240 tablets 67544-002-90 300 tablets 67544-002-93
Rx only Generic On market CIII ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67544-002-80
Product NDC 67544-002
11-digit billing NDC 67544000280
NCPDP billing unit EA — each (per item)
RxCUI 993770, 993781, 993890
UNII GSL05Y1MN6, 362O9ITL9D
Application # ANDA040419
SPL Set ID d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1
Established class (EPC) Opioid Agonist
Mechanism of action Full Opioid Agonists
DEA schedule CIII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-07-06
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; CODEINE PHOSPHATE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 65991002050315
GPI class Acetaminophen-Codeine #3
GCN Seq No 004165
GCN 70134
HICL code 001717
Ingredient (HICL) Acetaminophen With Codeine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3U
Therapeutic class — specific (HIC3) Opioid Analgesic And Non-Salicylate Analgesics
AHFS code 28:08.08.00
AHFS class Opioid Agonists (28:08)
FDB label name ACETAMINOPHEN-COD #3 TABLET
FDB brand name Acetaminophen-Codeine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • 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): 993770
Why two NDCs? The FDA registers this code as 67544-002-80 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 67544-0002-80. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ACETAMINOPHEN-COD #3 TABLET Ingredient Acetaminophen With Codeine
📗 Our plain-language guide HelloPharmacist
  • 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.
📖 Read our full Acetaminophen and Codeine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer 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 $90.16 / 180 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
67544-0002-09 67544-002-09 Main listing 9 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-15 67544-002-15 15 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-20 67544-002-20 20 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-30 67544-002-30 30 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-40 67544-002-40 40 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-45 67544-002-45 45 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-46 67544-002-46 56 TABLET in 1 BOTTLE, PLASTIC 2021-07-28 — Active
67544-0002-50 67544-002-50 50 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-53 67544-002-53 60 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-54 67544-002-54 84 TABLET in 1 BOTTLE, PLASTIC 2021-08-04 — Active
67544-0002-55 67544-002-55 75 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-60 67544-002-60 90 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-70 67544-002-70 120 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-72 67544-002-72 112 TABLET in 1 BOTTLE, PLASTIC 2021-08-10 — Active
67544-0002-75 67544-002-75 150 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-80 You're viewing this 180 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-85 67544-002-85 200 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-90 67544-002-90 240 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active
67544-0002-93 67544-002-93 300 TABLET in 1 BOTTLE, PLASTIC 2011-07-06 — Active

You're viewing one of 19 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 180-count package — 180 tablet in 1 bottle, plastic.
How does this package differ from NDC 67544-0002-09?
Both are Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet — the drug itself is identical. This page's package is the 180-count one, while NDC 67544-0002-09 is the 9 tablets package.
What NDC number is used to bill for this package of Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 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 mgthis 67544-0002-80 Aphena 180 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Jul 2011
📍
2026
Currently FDA-listed
15 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeRound
Imprint4;M
Size11 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderSPECGX LLC
FDA applicationANDA040419 (ANDA)
Labeler code67544
First marketedJul 2011
DEA scheduleCIII
Product typeHuman Prescription Drug
Portfolio800 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 93 words ▾

WARNING: 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 4000 milligrams per day, and often involve more than one acetaminophen-containing product ( see WARNINGS ). WARNING: 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.

🎯 Indications and Usage 19 words ▾

INDICATIONS AND USAGE Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.

⏱️ Dosage and Administration 153 words ▾

DOSAGE AND ADMINISTRATION Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage is: Single Doses (Range) Maximum 24-Hour Dose Codeine Phosphate 15 mg to 60 mg 360 mg Acetaminophen 300 mg to 1000 mg 4000 mg Doses may be repeated up to every 4 hours. 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.

⛔ Contraindications 34 words ▾

CONTRAINDICATIONS Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

⚠️ Warnings ~3 min read ▾

WARNINGS 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 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious Skin Reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations).

Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine ( see PRECAUTIONS, Nursing Mothers ). Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs.

Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels.

Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) ( see OVERDOSAGE ). Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy ( see CONTRAINDICATIONS ).

When prescribing codeine-containing products, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose ( see OVERDOSAGE ). Hypersensitivity/Anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting.

There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue acetaminophen and codeine phosphate tablets USP immediately and seek… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 76 words ▾

ADVERSE REACTIONS The most frequently observed adverse reactions include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, and agranulocytosis.

At higher doses, codeine has most of the disadvantages of morphine including respiratory depression.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Following an acute overdosage, toxicity may result from codeine or acetaminophen. Signs and Symptoms Toxicity from codeine poisoning includes the opioid triad of pinpoint pupils, depression of respiration, and loss of consciousness. Convulsions may occur.

In acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include nausea, vomiting, diaphoresis and general malaise.

Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment A single or multiple drug overdose with acetaminophen and codeine is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For respiratory depression due to overdosage or unusual sensitivity to codeine, parenteral naloxone is a specific and effective antagonist.

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 or more hours 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 ~1 min read ▾

CLINICAL PHARMACOLOGY This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen. Pharmacokinetics The behavior of the individual components is described below. Codeine – Codeine is rapidly absorbed from the gastrointestinal tract.

It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues.

The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (4%), and hydrocodone (1%).

The remainder of the dose is excreted in the feces. At therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours. Acetaminophen – Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues.

The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg.

It is available as a round, white to off-white tablet debossed with “2” on one side and an M on the other side. Bottles of 100......................................... NDC 0406-0483-01 Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg.

It is available as a round, white to off-white tablet debossed with “3” on one side and an M on the other side. Bottles of 20........................................... NDC 0406-0484-20 Bottles of 30...........................................

NDC 0406-0484-03 Bottles of 50........................................... NDC 0406-0484-50 Bottles of 100......................................... NDC 0406-0484-01 Bottles of 1000.......................................

NDC 0406-0484-10 Unit Dose (10 x 10)............................... NDC 0406-0484-62 Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. It is available as a round, white to off-white tablet debossed with “4” on one side and an M on the other side.

Bottles of 100......................................... NDC 0406-0485-01 Bottles of 500......................................... NDC 0406-0485-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container as defined in the USP. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and M are trademarks of a Mallinckrodt company. © 2013 Mallinckrodt. Mallinckrodt Inc.

Hazelwood, MO 63042 USA Rev 10/2013 Mallinckrodt™ Pharmaceuticals

📋 Description ~1 min read ▾

DESCRIPTION Acetaminophen and codeine phosphate is 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: 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 Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains: Acetaminophen USP . . . . . . . . . . . . . 300 mg Codeine Phosphate USP . . . . . . . . . . . . . 15 mg (Warning: May be habit forming) Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains: Acetaminophen USP . . . . . . . . . . . . .

300 mg Codeine Phosphate USP . . . . . . . . . . . . . 30 mg (Warning: May be habit forming) Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains: Acetaminophen USP . . . . . . . . . . . . . 300 mg Codeine Phosphate USP . . . . . . . . . . . . .

60 mg (Warning: May be habit forming) In addition, each Acetaminophen and Codeine Phosphate Tablet USP contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid. Acetaminophen Chemical Structure Codeine Phosphate Chemical Structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Acetaminophen and codeine phosphate tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison’s disease, or prostatic hypertrophy. Information for Patients/Caregivers Do not take acetaminophen and codeine phosphate tablets USP if you are allergic to any of its ingredients.

If you develop signs of allergy such as a rash or difficulty breathing, stop taking acetaminophen and codeine phosphate tablets USP and contact your healthcare provider immediately. Do not take more than 4000 milligrams of acetaminophen per day. Call your healthcare provider if you took more than the recommended dose.

Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Avoid such tasks while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product.

Avoid drinking alcohol or taking other CNS depressants when you are taking acetaminophen and codeine phosphate tablets USP. Codeine may be habit-forming. Take this drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid codeine metabolizer or not. These higher-than-normal levels of morphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing.

Children with this genetic variation who were prescribed codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. Codeine-containing products are contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving codeine-containing products for other reasons to monitor for signs of respiratory depression.

Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. If you are a nursing mother, watch for signs of morphine toxicity in your infant, including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness.

Talk to your baby’s doctor immediately if you notice these signs. If you cannot reach the doctor right away, take your baby to an emergency room or call 911 (or local emergency services). Laboratory Tests In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions This drug may enhance the effects of other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. Drug/Laboratory Test Interactions Codeine may increase serum amylase levels. Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether acetaminophen and codeine have a potential for carcinogenesis or mutagenesis. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for impairment of fertility. Acetaminophen and codeine have been found to have no mutagenic potential using the Ames Salmonella-Microsomal… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 51 words ▾

PRINCIPAL DISPLAY PANEL - 15/300mg NDC 67544-001 - Codeine Phosphate/APAP 15/300mg - Rx Only Bottle Label 15/300mg

PRINCIPAL DISPLAY PANEL - 30/300mg NDC 67544-002 - Codeine Phosphate/APAP 30/300mg - Rx Only Bottle Label 30/300mg

PRINCIPAL DISPLAY PANEL - 60/300mg NDC 67544-003 - Codeine Phosphate/APAP 60/300mg - Rx Only Bottle Label 60/300mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
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) — 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 18 other package presentations of this same product, including 9 tablets (67544-0002-09), 15 tablets (67544-0002-15), 20 tablets (67544-0002-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 67525-0400-01 · Spectrum 67544-0003-53 · Aphena →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.