Acetaminophen 300 MG Codeine Phosphate 60 MG Oral Tablet

INDICATIONS AND USAGE Acetaminophen and Codeine Phosphate Tablets, USP 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, even at recommended doses [see WARNINGS ], reserve Acetaminophen and Codeine Phosphate Tablets, USP for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] • Have not provided adequate analgesia, or are not expected to provide adequate analgesia, • Have not been tolerated, or are not expected to be tolerated.

sun pharmaceutical industries, inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] seizure` `[4] nausea` `[5] fatigue` `[6] headache` `[7] dyspnoea` `[8] diarrhoea` `[9] pyrexia` `[10] vomiting`

4 years ago

ROUND WHITE RX 561 4

HOW SUPPLIED

ACETAMINOPHEN AND CODEINE PHOSPHATE Tablets, USP 300 mg/30 mg are white, round, tablets, debossed “ RX ” over “ 562 ” on one side and “ 3 ” on the other side. Each tablet contains 300 mg of acetaminophen, USP and 30 mg of codeine phosphate, USP. They are supplied as follows: NDC 63304-562-01 Bottles of 100 NDC 63304-562-05 Bottles of 500 NDC 63304-562-10 Bottles of 1000

ACETAMINOPHEN AND CODEINE PHOSPHATE Tablets, USP 300 mg/60 mg are white, round, tablets, debossed “ RX ” over “ 561 ” on one side and “ 4 ” on the other side. Each tablet contains 300 mg of acetaminophen, USP and 60 mg of codeine phosphate, USP. They are supplied as follows: NDC 63304-561-01 Bottles of 100 NDC 63304-561-05 Bottles of 500 Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Protect from light. Do not refrigerate. Do not freeze. Dispense in tight, light-resistant container as defined in the USP. Store

ACETAMINOPHEN AND CODEINE PHOSPHATE Tablets, USP securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured by: CorePharma LLC Middlesex, NJ 08846 USA Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512 August 2020 FDA-20

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