acetaminophen and codeine tablet

INDICATIONS AND USAGE Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of ADDICTION, ABUSE, AND MISUSE with opioids, which can occur at any dosage or duration (see WARNINGS ), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Have not been tolerated or are not expected to be tolerated. Have not provided adequate analgesia or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

amneal pharmaceuticals llc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] fatigue` `[4] pain` `[5] nausea` `[6] headache` `[7] dyspnoea` `[8] pyrexia` `[9] toxicity to various agents` `[10] arthralgia`

5 years ago

ROUND WHITE IP33 3

5 years ago

IP33 3 ROUND WHITE

HOW SUPPLIED

ACETAMINOPHEN AND CODEINE Phosphate Tablets, USP, 300 mg/30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse. They are available as follows: Bottles of 100: NDC 65162-033-10 Bottles of 500: NDC 65162-033-50 Bottles of 1,000: NDC 65162-033-11 Store

ACETAMINOPHEN AND CODEINE Phosphate Tablets, USP 300 mg/30 mg between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Store

ACETAMINOPHEN AND CODEINE phosphate tablets securely and dispose of properly (see PRECAUTIONS; Information for Patients/ Caregivers ). Manufactured by: Amneal Pharmaceuticals of NY, LLC Brookhaven, NY 11719 Rev. 01-2024-13 Dispense with Medication Guide available at: documents.amneal.com/mg/apap-codeine.pdf

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