All about Drug Labels

Medicines are an integral part of life. Awareness should be created in the public to observe the drug label for safe and effective use of medicine. For that, it is important to understand what is displayed in the label of a drug that has certain identifying information.

Are there any rules framed for labeling of drugs?
The rules of drug labeling are framed under the “Drugs and Cosmetic Act 1940.” The International Pharmaceutical Federation (FIP) has developed international guidelines for the labeling of medicines which are published on their website.

How is the name of a drug displayed on the label?
A drug or the main active pharmaceutical ingredient can be represented by 3 names:

  • Generic name: It is the official medical name for the basic active substance or active pharmaceutical ingredient, which is chosen by the nomenclature committee of the British Pharmacopoeia Commission.
  • Brand name or trade name: It is chosen by the manufacturer usually on the basis that it can be easily pronounced, recognised, or remembered. For example, paracetamol is the generic name. Calpol, Acetaminophen, Crocin, Dolo, etc. are the brand names or the trade names of the paracetamol which is given by different manufactures.
  • Chemical name: It is a technical description of the drug. For example, Paracetaminophenol is the chemical name of paracetamol.

What is the meaning of the letters IP, BP, USP, BNF which follows the strength of the medicine?
These are short forms for the official books for standards of particular countries according to which the drugs are manufactured and known as pharmacopoeia. The abbreviations are as follows:

  • Indian pharmacopoeia IP
  • British pharmacopoeia BP
  • United States pharmacopoeia USP
  • British National Formulary BNF

What is meant by expiry date?
The expiry date displayed on the container of a pharmaceutical starting raw material is the date up to and including which the pharmaceutical starting material is expected to remain within specification if stored correctly. The drug can be used by the last date of that particular month displayed as expiry date (if exact date is not specified).

What is Schedule H drug and Schedule G drug?
To ensure the availability of proper and standard drugs to the public, there are effective laws in various countries. The law in India is the “Drugs and Cosmetic Act 1940.” Generally, drugs are divided into two - prescription only drugs and over the-counter drugs.

  • Schedule H: The list of substances that should be sold by retail only on prescriptions of registered medical practitioners.
  • Over-the-counter drugs (OTC medicines): These are drugs that can be sold from licensed dealers without professional supervision and without prescription. These drugs are suitable for self-medication for minor diseases and symptoms. The consumer should know the safe use of OTC medicines if they are administered without medical advice. Long-term use is not advisable. It is proved that even paracetamol, which is well known as the safest painkiller can cause liver damage in high doses and prolonged use.
  • Schedule G: The list of substances that are required to be used only under medical supervision and which are required to be labeled accordingly.

What about the other warnings and directions on the label?
Sometimes, special directions for use are displayed on the label.

Route of administration: Some drugs produce the required therapeutic action only when they are administered through the particular route. For example, insulin, the anti- diabetic drug, should be administered subcutaneously, as it is degraded by the enzymes in the gastro-intestinal tract if it is administered through the oral route.

  • i.v/i.m: only for injections.
  • Oral: for the drugs which can be administered through mouth.
  • Sublingual: for drugs which should be placed under tongue.
  • For external use only - For drugs meant for external use (should not be taken internally) for example, creams, gels, etc.
  • For nasal use only - for drugs to instill in the nose.
  • Shake well before use - For suspensions like antacids(Gelucil). Suspensions are havinga tendency to settle at the bottom of the container. So, if it is not mixed properly, the body will not be getting proper amount of active ingredients for the therapeutic action.

Keep out of reach of children
Sugar-coated and beautifully- colouredtablets/capsules are available - for example iron tablets. Children may mistake them for candy, so they must be stored out of reach of children. (If they are ingested in large numbers, it may lead to drug toxicity.)

For eye drops, use within one month
It is displayed on the labels that “use the solution within one month after opening the container.” This means, if anything is remaining in the container after one month that should not be used.

(Similarly, the dry syrup for children should be reconstituted according to the direction on the label with boiled and cooled water. But the reconstituted liquid syrup will expire after 2 weeks. So it should not be given to children after 2 weeks.)

Storage conditions
Storage conditions should be recommended on the label (example “Keep in a cool, dry place”) to maintain drug stability — i.e., to prevent contamination and as far as possible deterioration. It may be necessary to control elements such as temperature, moisture and light. If not stored properly, the medicine may expire well before the expiry date.

  • Cold — 2-8°c
  • Cool — 8-25°c
  • Room temperature — Temperature prevailing in a working area
  • Warm — 30-40°c
  • Excessive heat — above 40°c
  • Valium (Diazepam) — do not store above 30°c
  • Ointments should be kept below30°c. Do not freeze.

Protection from freezing
It is indicated where there is a risk of breaking the container or where freezing leads to loss of strength or potency.

Not to be refrigerated
For example, soft gelatin capsules should not be refrigerated.

Protection from light
Store in a dark cupboard or use a light-resistant container.

Physician’s sample — not to be sold
The label of sample drugs should display this. Sample drugs are not meant for sale.

Dosage as directed by the physician
The dose of a drug or the time interval between the doses is never increased or decreased unless directed by the physician. In most situations, drugs are administered in such a way as to maintain a steady state of drug in the body. The extent to which patients follow the instructions of doctor on medicine is called adherence or compliance.

It is often found that the patients do not follow or fail the dosage schedule prescribed for them. Non- adherence can worsen the quality of life.
For example, missed doses of medicines of heart problems may lead to more complications.

In the case of antibiotic therapy, missed doses of medicines are not only the problem of individual patients but are a global threat, as it leads to subtherapeutic exposure of these medicines.

The drug becomes ineffective at the moment and also ineffective permanently due to the development of new strains of bacteria which is capable of drug resistance. The result is new powerful drugs have to be developed and introduced to get the germ-killing effect.

Thus, try to develop a habit to observe the label of each and every drug.

That will help you in proper usage and storage of drugs. If any doubt arises, ask your pharmacist for help.

Comments 1 comment

Yogesh kumar 19 months ago

Enough knowledge............ thanx

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