Acetaminophen and Codeine Phosphate Acetaminophen 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.

Teva Pharmaceuticals USA Inc

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

5 years ago

ROUND WHITE 3 TV 150 [or] 93 150 3

HOW SUPPLIED Acetaminophen and codeine phosphate tablets USP (white, round, unscored): List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01 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. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from moisture. PROTECT FROM LIGHT. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store acetaminophen and codeine phosphate tablets securely and dispose of properly [see PRECAUTIONS ; Information for Patients/Caregivers ]. Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. AT 7/2020

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