Because this medication contains codeine, an opioid, it carries a high risk for dependency and misuse. It is strictly regulated to prevent abuse and ensure patient safety.

It is illegal to purchase or possess this medication without a prescription. Legitimate pharmacies will not dispense it without a doctor's authorization.

Obtaining this medication from unregulated online sources is dangerous. Such products may be counterfeit, contaminated, or contain incorrect dosages, posing a severe threat to health.

This medication is not intended for use in children under the age of 12 and is generally not recommended for adolescents between 12 and 18 years of age due to the risk of severe breathing problems.

The FDA has issued a "black box warning" for this medication due to the risks of respiratory depression, addiction, and potential fatality, especially if misused or combined with other central nervous system depressants like alcohol.