Codeine Sulf 60 mg Tablets, 100 Tablets/Bottle

Codeine sulfate — 60MG, Tablet, bottle of 100 tablets

Codeine sulfate is a tablet for oral use. 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.

• Active ingredient or product type: CODEINE SULFATE
• Strength/concentration: 60MG
• Dosage form and route: Tablet, Oral
• Exact package presentation: bottle of 100 tablets
• NDC/item number: 0054-0245-25
• Manufacturer: HIKMA PHARMACEUTICALS USA INC
• Storage/handling: Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Store Codeine Sulfate Tablets securely and dispose of properly.
• Status: Rx only

Important safety information: • Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.