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These highlights do not include all the information needed to use CODEINE SULFATE TABLETS safely and effectively. See full prescribing information for CODEINE SULFATE TABLETS. CODEINE SULFATE tablets, for oral use CIIInitial U.S. Approval: 1950
Medication labelWhy this: Advisory · dailymed-prescription
Codeine Sulfate 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including Codeine Sulfate Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- generic_name
- codeine sulfate
- product_names
- codeine sulfate
- ndc
- 0054-0243, 0054-0244, 0054-0245, 0054-0243-24, 0054-0245-25, 0054-0244-25, 0054-0244-24
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en