Home › NDC Lookup › Ingredients › Acetaminophen And Codeine Phosphate › 49999-0060-30
Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet, 30-count — NDC 49999-0060-30 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, 30-count — NDC 49999-060-30 (Billing 49999-0060-30)

by Quality Care Products, LLC · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet from Quality Care Products, LLC, no longer marketed (first marketed Sep 2011), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 3 package sizes.

NDC 49999-0060-30
🏷️ FDA NDC (as labeled) 49999-060-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Main listing for product 49999-060 · Also comes in: 60 tablets 49999-060-60 90 tablets 49999-060-90
Rx only Generic Discontinued CIII ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49999-060-30
Product NDC 49999-060
11-digit billing NDC 49999006030
NCPDP billing unit EA — each (per item)
RxCUI 993781
UNII 362O9ITL9D, GSL05Y1MN6
Application # ANDA040419
SPL Set ID 3b455938-7bbc-4626-939b-40b37709befb
Established class (EPC) Opioid Agonist
Mechanism of action Full Opioid Agonists
DEA schedule CIII
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2011-09-14
Marketing end 2026-09-30
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): 993781
Why two NDCs? The FDA registers this code as 49999-060-30 — 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 → 49999-0060-30. 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
📖 What it is MedlinePlus · NLM

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 ↗
📗 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 tablets 90 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
49999-0060-30 You're viewing this Main listing 30 TABLET in 1 BOTTLE 2011-09-14 — Discontinued by firm
49999-0060-60 49999-060-60 60 TABLET in 1 BOTTLE 2011-09-14 Sep 30, 2026 Active
49999-0060-90 49999-060-90 90 TABLET in 1 BOTTLE 2011-09-14 — Discontinued by firm

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 bottle.
How does this package differ from NDC 49999-0060-60?
Both are Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 49999-0060-60 is the 60 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 mgthis 49999-0060-30 Quality 30 tablets — AA Discontinued —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 50090-4610-00 A-S 10 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 50090-4611-01 A-S 16 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 58118-4484-08 Clinical 30 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 60760-0581-30 St. 30 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 60760-0938-30 ST. 30 tablets — AA FDA listed —
Acetaminophen And Codeine 300 mg/1; 30 mg 61919-0484-18 Direct_Rx 18 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 63187-0106-15 Proficient 15 tablets — AA FDA listed —
Acetaminophen and Codeine 300 mg/1; 30 mg 63187-0491-20 Proficient 20 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 63187-0815-15 Proficient 15 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 63629-5666-01 Bryant 10 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 64850-0642-12 Elite 120 tablets — AA FDA listed —
Acetaminophen and Codeine 300 mg/1; 30 mg 67296-1772-06 RedPharm 6 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 67296-2239-02 Redpharm 6 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 67544-0002-09 Aphena 9 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68071-3651-06 NuCare 6 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68071-3658-02 NuCare 20 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 68071-3798-06 NuCare 6 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 68071-3824-06 NuCare 6 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68071-4475-02 NuCare 12 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68071-4533-02 NuCare 20 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 68071-4673-02 NuCare 20 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 68071-5010-04 NuCare 4 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 68788-7835-01 Preferred 15 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 70518-2628-00 REMEDYREPACK 30 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 70518-3705-00 REMEDYREPACK 30 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 70518-4104-00 REMEDYREPACK 30 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 71335-0256-00 Bryant 40 tablets — AA FDA listed —
Acetaminophen and Codeine 300 mg/1; 30 mg 71335-0545-00 Bryant 40 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 71335-1522-00 Bryant 40 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 71335-1818-00 Bryant 40 tablets — AA FDA listed —
Acetaminophen and Codeine Phosphate 300 mg/1; 30 mg 71335-2916-00 Bryant 40 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 mg 72162-2001-01 Bryant 100 tablets — AA FDA listed —
Acetaminophen and Codeine 300 mg/1; 30 mg 76420-0103-03 Asclemed 3 tablets — AA FDA listed —
Acetaminophen And Codeine Phosphate 300 mg/1; 30 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
Sep 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
Imprint3;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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
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

LabelerQuality Care Products, LLC
Application holderSPECGX LLC
FDA applicationANDA040419 (ANDA)
Labeler code49999
First marketedSep 2011
DEA scheduleCIII
Product typeHuman Prescription Drug
Portfolio70 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 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔒 Controlled Substance 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 50 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.

🎯 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 167 words ▾

DOSAGE AND ADMINISTRATION Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage for tablets 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 The usual dose of codeine phosphate in children is 0.5 mg/kg. 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 18 words ▾

CONTRAINDICATIONS This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

⚠️ Warnings 1 words ▾

WARNINGS

🤒 Adverse Reactions 75 words ▾

ADVERSE REACTIONS The most frequently reported adverse reactions are 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, agranulocytosis.

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

🔄 Drug Interactions 28 words ▾

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 20 words ▾

Drug/Laboratory Test Interactions Codeine may increase serum amylase levels. Acetaminophen may produce false positive test results for urinary 5-hydroxyindoleacetic acid.

🤰 Pregnancy 155 words ▾

Pregnancy Teratogenic Effects. Pregnancy Category C Codeine – A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation.

In another study a single 100 mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no adequate and well-controlled studies in pregnant women. Acetaminophen and codeine phosphate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. These signs usually appear during the first few days of life.

🆘 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 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 ~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 readily 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. See OVERDOSAGE for toxicity information.

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. See OVERDOSAGE for toxicity information.

📦 How Supplied / Storage and Handling 184 words ▾

HOW SUPPLIED 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. 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. 49999-060-06 49999-060-15 49999-060-12 49999-060-10 49999-060-20 49999-060-24 49999-060-30 49999-060-50 49999-060-60 49999-060-90 49999-060-00 49999-060-01 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.

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. is a trademark of Mallinckrodt Inc. Mallinckrodt Inc.

Hazelwood, MO 63042 USA Rev 06/2011 Mallinckrodt COVIDIEN™ Imprint Code

📋 Description 179 words ▾

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/30 mg) contains: Acetaminophen USP . . . . . . . . . . . . . 300 mgCodeine Phosphate USP . . . . . . . . . . . . . 30 mg Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains: Acetaminophen USP . . . . . . . . . . . . .

300 mgCodeine Phosphate USP . . . . . . . . . . . . . 60 mg 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

💬 Information for Patients ~1 min read ▾

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 doctor if you took more than the recommended dose. Codeine may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.

Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided. Codeine is habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

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. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness.

Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

⚠️ 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. Ultra-rapid Metabolizers of Codeine - Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. 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 regiments, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. 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 is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose ( see PRECAUTIONS, Nursing Mothers ). 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 doctor if you took more than the recommended dose.

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

Codeine is habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people.

These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. 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. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the 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 p… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers ~2 min read ▾

Nursing Mothers Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from acetaminophen, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Codeine is secreted into human milk.

In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine.

These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. 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 is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman.

If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.

Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding ( see PRECAUTIONS, General, Ultra-rapid Metabolizers of Codeine ).

🔒 Controlled Substance 15 words ▾

Controlled Substance Acetaminophen and codeine phosphate tablets are classified as a Schedule III controlled substance.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 77 words ▾

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 Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow.

📄 Package Label / Principal Display Panel 2 words ▾

image description

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 No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 tablets (49999-0060-60), 90 tablets (49999-0060-90). 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?
Quality Care Products, 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.
← 49999-0046-14 · Lake 49999-0126-30 · Quality →
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.