Acetaminophen and Codeine Phosphate 300 mg/1
Acetaminophen and Codeine Phosphate · TABLET · Aurolife Pharma, LLC
Acetaminophen and codeine phosphate is a prescription pain reliever tablet that combines a fever reducer with an opioid to treat moderate pain. This medication is taken by mouth and should be used only as directed by your doctor.
Key Facts
- Brand Name
- Acetaminophen and Codeine Phosphate
- Generic Name
- Acetaminophen and Codeine Phosphate
- NDC Code (Product)
13107-059- Manufacturer
- Aurolife Pharma, LLC
- Strength
- 300 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA202800
- Marketing Start
- 04/15/2013
Recall History
H J Harkins Company Inc dba Pharma Pac
cGMP Deviations
Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Qualitest Pharmaceuticals
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Dosage & Administration
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Acetaminophen and codeine phosphate tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Acetaminophen and codeine phosphate tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, ta…
Warnings
WARNINGS Addiction, Abuse and Misuse: Acetaminophen and codeine phosphate tablets contain codeine. Codeine in combination with acetaminophen, is a Schedule III controlled substance. As an opioid, acetaminophen and codeine phosphate tablets expose users to the risks of addiction, abuse, and misuse [see DRUG ABUSE and DEPENDENCE ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed acetaminophen and codeine phosphate tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [ see ADVSERVE REACTIONS ]. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing acetaminophen and codeine phosphate tablets, and reassess all patients receiving acetaminophen and codeine phosphate tablets for the development of these behaviors and conditions. Risks are increased in patients with a p…
Contraindications
CONTRAINDICATIONS Acetaminophen and codeine phosphate tablets are contraindicated for: • All children younger than 12 years of age (see WARNINGS ). • Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy ( see WARNINGS ) . Acetaminophen and codeine phosphate tablets are contraindicated in patients with: • Significant respiratory depression [ see WARNINGS ]. • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see WARNINGS ] . • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [ see WARNINGS ] . • Known or suspected gastrointestinal obstruction, including paralytic ileus [ see WARNINGS ] . • Hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) [ see WARNINGS ] .
Adverse Reactions
ADVERSE REACTIONS •The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see WARNINGS ] • Life-Threatening Respiratory Depression [see WARNINGS ] • 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 ] • Opioid-Induced Hyperalgesia and Allodynia [See Warnings ] The following adverse reactions associated with the use of codeine were identified in post marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions associated with codeine are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest. The most frequently observed adverse reactions with codeine administration include drowsiness, lightheadedness…
Frequently Asked Questions
What is Acetaminophen and Codeine Phosphate used for?
Acetaminophen and codeine phosphate is a prescription pain reliever tablet that combines a fever reducer with an opioid to treat moderate pain. This medication is taken by mouth and should be used only as directed by your doctor.
Is Acetaminophen and Codeine Phosphate a controlled substance?
Yes, Acetaminophen and Codeine Phosphate is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Acetaminophen and Codeine Phosphate?
The generic name for Acetaminophen and Codeine Phosphate is Acetaminophen and Codeine Phosphate. There are 8 other brand versions of Acetaminophen and Codeine Phosphate.
What is the NDC code for Acetaminophen and Codeine Phosphate 300 mg/1?
The NDC (National Drug Code) for Acetaminophen and Codeine Phosphate 300 mg/1 is 13107-059, listed by Aurolife Pharma, LLC.
Other Acetaminophen Brands
See all →- ACETAMINOPHEN AND CODEINE PHOSPHATE300 mg/150090-4610
- ACETAMINOPHEN AND CODEINE PHOSPHATE300 mg/10406-0485
- ACETAMINOPHEN AND CODEINE PHOSPHATE300 mg/171930-054
- ACETAMINOPHEN AND CODEINE PHOSPHATE300 mg/158118-0485
- ACETAMINOPHEN AND CODEINE PHOSPHATE300 mg/168071-2681
- ACETAMINOPHEN AND CODEINE PHOSPHATE300 mg/168071-4475
- ACETAMINOPHEN AND CODEINE PHOSPHATE300 mg/171335-1818
- ACETAMINOPHEN AND CODEINE PHOSPHATE300 mg/172162-2001
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)