Acetaminophen 300 MG Codeine Phosphate 15 MG Oral 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

Aurolife Pharma, LLC

FDA Reported Adverse Reactions
`[1] drug dependence` `[2] pain` `[3] overdose` `[4] drug ineffective` `[5] fatigue` `[6] off label use` `[7] emotional distress` `[8] rash` `[9] nausea` `[10] headache`

4 years ago

ROUND WHITE U35

4 years ago

U35 ROUND WHITE

HOW SUPPLIED

ACETAMINOPHEN AND CODEINE PHOSPHATE tablets, USP are supplied as follows: 300 mg/15 mg white to off-white, round, flat-faced, beveled-edged tablets, debossed with “U35” on one side and plain on the other side. Bottles of 30 NDC 13107-058-30 Bottles of 100 NDC 13107-058-01 Bottles of 500 NDC 13107-058-05 Bottles of 1000 NDC 13107-058-99 300 mg/30 mg white to off-white, round, flat-faced, beveled-edged tablets, debossed with “U36” on one side and plain on the other side. Bottles of 30 NDC 13107-059-30 Bottles of 100 NDC 13107-059-01 Bottles of 500 NDC 13107-059-05 Bottles of 1000 NDC 13107-059-99 300 mg/60 mg white to off-white, round, flat-faced, beveled-edged tablets, debossed with “U37” on one side and plain on the other side. Bottles of 30 NDC 13107-060-30 Bottles of 100 NDC 13107-060-01 Bottles of 500 NDC 13107-060-05 Bottles of 1000 NDC 13107-060-99 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store

ACETAMINOPHEN AND CODEINE PHOSPHATE tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients ]. Keep this and all medication out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as described in the USP. PROTECT FROM LIGHT Dispense with Medication Guide available at https://www.aurobindousa.com/medication-guides / Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised:12/2023

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