Tuesday, July 6, 2010

Drug labels

It is vital to follow the doctor's or the pharmacist's instruction when taking medication. Refer to the instructions on the medicine label. When in doubt, consult your doctor or pharmacist.

Labels for the medicine's immediate containers, blisters, outer cartons (if any) or dispensing labels should follow each country's medicine labeling requirements or guidance. Refer to each country specific labeling requirements.

In Malaysia, normally, these should be present on the medicine's outer carton (if any):
  • Product Name
  • Dosage Form
  • Name of active ingredient(s)
  • Strength of active ingredient(s)
  • Batch No
  • Expiration Date
  • Route of Administration
  • Storage Condition
  • Country's Registration No
  • Name and Address of Marketing Authorization (Product Licence) Holder
  • Name and Address of Manufacturer
  • Warnings (if applicable)
  • Pack Sizes
  • Name and Content of Preservative(s) (if any)
  • Name and Content of Alcohol (if any)
  • Source of ingredient derived from animal origin , including gelatin (active, excipient and/or capsule shell)
  • Recommended Daily Allowance (RDA) for vitamins, multivitamins and mineral preparations used as dietary supplements.
  • The words `Keep medicine out of reach of children'
  • Other country specific labeling requirements (if applicable). Examples are the word `Controlled Medicine' for controlled medicine only, the word `For External Use Only' for external use medicine and hologram tag.
 Meanwhile, the dispensing labels shall contain:
  • Name and Address of the supplier/seller (clinic or pharmacy)
  • The patient's name
  • Date of medicine supplied/sold
  • Reference no (especially for the prescription drugs entry)
  • Full name of the medicine (Not just the drug's usage!!)
  • Strength of the medicine
  • Adequate directions for the use of the medicine.
  • The word `Controlled Medicine' for the controlled medicine only.