Prescription Product Labeling
Proper labeling is one of the most important aspects of dispensing a prescription. The label must comply with state and federal regulations and should correctly and clearly convey all necessary information regarding dosage, mode of administration, and proper storage of the product. The quality of the labeling is extremely important to the patient's perception of the quality of the product and may have profound implications for his or her safe use of the medication and compliance with the prescribed regimen.
Required Label Information
Most pharmacies have the name, address, and phone number of the pharmacy pre-printed on their prescription labels. In addition, federal and state (NC) regulations require that the following information appear on the label.
- prescription (serial) number
- date of initial dispensing
- patient's name
- directions for use
- name and strength of the drug product (or active ingredient(s) in a compounded prescription)
- prescriber's name
- name of dispensing pharmacist
- beyond-use date
Labels for controlled substances in schedule II, III, and IV must also contain the statement "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." in the form of an auxiliary label.
Recommended Label Infromation
In addition to the information required by law, it is recommended that the following information also be provided on the prescription label.
- Number of dosage units or volume of product dispensed
- Number of refills allowed
You should consider these to be label requirements for the course.
Presented below is an example of a proper label. This is the format which you should follow in the course.
UNC School of Pharmacy
Chapel Hill, NC 27511
Rx # 123456 Dr. Upendown
Pat Annsir 9/1/01
Take one tablet every four to six hours as needed for pain.
Acetaminophen 325 mg, Codeine sulfate 15 mg/tablet (#30)
3 refills; Discard after 9/31/01
Dispensed by Y. Ourname R.Ph.
Other Labeling Guidelines
- Indicate the dosage form to be administered.
e.g. "Take one tablet every day." instead of "Take one every day."
- Use words instead of numbers.
e.g. "Take one tablet every day" instead of "Take 1 tablet every day."
- Express quantities to be administered in units which are familiar to the patient, and for which they are likely to have suitable measuring devices.
e.g. "Take two teaspoonfuls every six hours." instead of "Take 10 ml. ..."
In some instances it may be critical that an exact volume, such as 2.0 ml, be administered. In such a case, the pharmacist should provide a properly calibrated measuring device along with the medication.
- Specify the route of administration if the medication is not intended for oral use.
e.g. Insert one suppository vaginally every night at bedtime.
- Do not use abbreviations.
e.g. "Take two capsules twice a day." not "Take two caps twice a day."
- Specify all active ingredients in a compounded prescription. Inert bases or vehicles may, but need not, be labeled.
- In general, the amount of active ingredient per dosage unit should be specified. e.g. Inderal 2 mg/chart, Amoxicillin 250 mg/5ml., Phenergan 25 mg/suppository.
- When dispensing medications in bulk, such as solutions, suspensions, emulsions, ointments, or creams, the amounts of active ingredients are expressed as a percentage strength. This is almost always true of topical preparations.
e.g. Hydrocortisone cream 1% or Betadine solution 2%