APAP 300 MG codeine phosphate 30 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, even at recommended doses [see WARNINGS ], reserve acetaminophen and codeine phosphate tablets 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.

Mylan Institutional Inc.

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

9 years ago

ROUND WHITE TV 150 3

9 years ago

TV 150 3 ROUND WHITE

HOW SUPPLIED: Acetaminophen and codeine phosphate tablets USP (white, round, unscored): List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet is available as follows: NDC 51079-161-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12453 R2 8/18

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APAP 300 MG codeine phosphate 30 MG Oral Tablet

FDA Reported Adverse Reactions [1] fatigue [2] dyspnoea [3] nausea [4] diarrhoea [5] drug ineffective [6] dizziness [7] headache [8] asthenia [9] fall [10] off label use

ROUND WHITE TV 150 3

TV 150 3 ROUND WHITE

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Acetaminophen and Codeine Phosphate Acetaminophen 300 MG Codeine Phosphate 15 MG Oral Tablet

APAP 300 MG codeine phosphate 30 MG Oral Tablet

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