- Sumit Goel.
LABELING is a very important part of the finished product and completes the process of dispensing of the indicated medication. An improperly prepared label can decrease the patient's confidence in the preparation.
The labels on dispensed medicines should -
* Give the patient clear and complete instructions on how to take or use the preparation.
* Indicate the storage conditions necessary to ensure full potency throughout the period of treatment.
* Be neatly written and carefully displayed on the container, thus strengthening the patient's confidence in the preparation.
Labels may be hand written with indelible ink or ready-printed with the name and address of the physician or the pharmacy and, if desired, with certain common directions to the patient. Conventionally, the printing is red for the name of the medication and for labels of external preparations, the association of red with danger, helping to prevent accidental ingestion of the medicine.
The label must not be too small as the information will not be clearly legible. The size of the label should be proportionate to the size of the container.
INFORMATION ON THE LABEL
A. Name of the prescribed medication
The label should carry the name of the medicine with its potency and in case of external preparations, the name and nature of the preparation.
Proper name labeling is recommended for the following reasons - - The patient should be encouraged to understand his treatment.
- It prevents confusion when the patient is receiving different types of medications or medications are prepared for various members of the same family.
- It may be of help to the physician when the prescription of the previous treatment is not available.
Antagonists of this system argue that -
- It may lead to self-medication and misuse of the prescription.
- It may lead to a prejudice on the part of the patient in understanding the treatment.
B. The patient's name
Conventionally, it is written at the right hand side of the label so as to avoid confusion in dispensing by the dispenser and in storage by the patient.
C. The prescription book reference number and date Prescriptions recorded in a prescription book usually carry a serial number for identification. This allows the record to be traced easily if the patient brings the container and not the prescription when a further dose is needed. This is to be followed by the date of dispensing.
D. Directions for use and other information As per the needs, as felt by the physician, the specific directions for intake, usage, storage as well as restrictions of each medicine should be clearly stated on the label.
This also includes the mode of intake and the time of intake of the medicine.
SPECIFIC INSTRUCTIONS
* FOR EXTERNAL USE ONLY
This instruction and caution is essential in all preparations intended for application on the skin. Articles for application to mucous membranes should NOT have this instruction on this label.
* Medications for instillation into the mucous membranes like ear, eyes, rectum, vagina, etc. should have specific instructions as regards their usage.
* SHAKE WELL BEFORE USE This is necessary on all liquid disperse systems. If the dispersed phase separates and the container is not shaken before use, the patient will take low doses of medicament at first and high doses towards the end of the bottle. Several applications like 'shake lotions' are disperse systems and require this label It is needed also on any medicine, in which precipitation or separation could occur on storage like tinctures and syrups.
* STORE IN A COOL PLACE Storage in a cool place, i.e. at not more than 50C may be necessary for certain products like -
Creams: to prevent drying out
Ointments: to prevent loss of water, loss of volatile ingredients and structural breakdown.
Preparations containing volatile ingredients.
* PROTECT FROM LIGHT
This label is necessary when a light-sensitive preparation is packed.
* INFLAMMABLE
When any preparation containing 50 Pecent or more of alcohol or containing another inflammable solvent is dispensed or sold, it should carry the word - 'Inflammable'.
* EXPIRY DATE Depending on the stability of the medication and its storage life, the bottles should carry the expiry date or the storage life (e.g. USE WITHIN 6 MONTHS) on the container. Normally expiration dating is not required for homoeopathic drugs, if their labeling does not bear dosage limitations and they are stable for at least 3 years.
LABELING FOR MANUFACTURED HOMOEOPATHIC PRODUCTS The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any homoeopathic medicine and on every other covering in which the container is packed.
* The words 'HOMOEOPATHIC MEDICINE'.
* The name of the medicine.
* The potency of the homoeopathic medicine. For this purpose the potency shall be expressed either in decimal, centesimal or fifity millesimal scale. Appropriate symbols that are universally accepted and understood, may be mentioned on the label.
* Name and address of the manufacturer when sold in original containers of the manufacturer. In case the homoeopathic medicine is sold in a container other than that of the manufacturer, the name and address of the seller.
* In case the homoeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label. If the homoeopathic medicine contains any other ingredients, then it must be clearly stated on the label.
* No homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label
* The Manufacturing Date of the batch of homoeopathic medicine.
* The Expiry Date of the batch of homoeopathic medicines. This is required in certain preparations. Alternatively, the storage life may be mentioned.
* A distinctive batch number, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection; the figures representing the batch number being preceded by the words 'Batch No.' or 'Batch' or 'Lot No.'. As products are prepared in batches, the batch number helps in tracing out the entire batch in case of defect.
* Manufacturing License Number or 'Mfg. Lic. No.' is the license number of the manufacturer and indicates that the authority granting the license is satisfied with the conditions and that it is competent in manufacturing homoeopathic medicines.
* Instructions for storage and usage.
In addition to complying with the provisions of labelling laid down in the rules the following particulars should be shown on the label for OPHTHALMIC SOLUTIONS. (1) Of the containers (i) The statement 'Use the solution within one month after opening the container'.
(ii) Name and concentration of the preservative, if used.
(iii) The words 'NOT FOR INJECTION'.
(2) Of container or carton or package leaflet (i) Special instructions regarding storage, wherever applicable.
(ii) A cautionary legend reading as "WARNING: (a) If irritation persists or increases, discontinue use and consult physician.
(b) Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate solutions."
PACKAGE INSERTS The difficulty of including on the label of a small container of certain preparations, all the relevant details about the usage and storage of the product has led manufacturers to include 'information leaflet' inside the box enclosing the container of the medication. These can be considered extensions of the label and can include a lot of detailed instructions and information about the medicine.
CAUTION! - as per H.P.I. directions
* Acidum hydrocyanicum - HIGHLY POISONOUS! Handle carefully. All preparations upto 6X should be freshly prepared. Not to be dispensed below 6X.
* Acidum hydrofluoricum - Handle with care as it causes painful sores on the skin usually noticed on the next day only; avoid inhaling the vapors. Not to be dispensed below 4X. Preparations upto 6X to be freshly made.
* Acidum nitromuriaticum - HIGHLY CORROSIVE; Should not be brought in close contact with alcohol.
* Acidum picricum - Explosive when dry, rapidly heated or by percussion. Handle with care. For safety in transportation, it is mixed with 10 - 15 Pecent water. Not to be dispensed below 2X.
* Ammonium aceticum - Preparations below 3X to be freshly prepared.
* Ammonium picricum - VERY EXPLOSIVE; triturations upto 2X should be prepared in small quantities with great care.
* Antimonium chloridum - Not to be dispensed below 3X.
* Apis mellifica - Not to be dispensed below 3X.
* Argentum metallicum - Inhalation of dust should be avoided.
* Arsenicum album - Not to be dispensed below 3X.
* Aviaire - Handle with care and follow aseptic conditions upto 6X.
* Baryta carbonicum - Not to be dispensed below 3X.
* Calcarea caustica - All preparations of this medicine upto 6X should be freshly prepared. Preparations becoming turbid due to carbonic acid should be rejected.
* Iridium metallicum - The drug is non-radioactive and should not be mistaken for radio-active material (Iridium) whose atomic weight is 192. In order to make sure of the non-radio-active material, an appropriate photographic method for testing may be employed.
* Kali cyanatum - Deteriorates with moisture and acid fumes. Not to be dispensed below 6X. DEADLY POISON.
* Kali picricum - An explosive salt; to be prepared with care to avoid explosion. POISON! Not to be dispensed below 3X.
* Lachesis - Not to be dispensed below 6X.
* Medorrhinum - Not to be dispensed below 6X. 6X should be free from live germs and should pass the test for sterility.
* Radium bromatum - RADIOACTIVE; powerful corrosive; effect on skin; Handle with care. POISON! Not to be dispensed below 6X.
* Rhus toxicodendron - POISON! HANDLE WITH CARE; Not to be dispensed below 3X.
* Rhus venenata - The mother tincture poisons the skin. Handle with great care. Not to be dispensed below 3X.
* Shigella dysenteriae - Not to be dispensed below 6X. 6X should be free from live germs and should pass the test for sterility.
* Syphilinum - Not to be dispensed below 6X. 6X should be free from live germ and should pass the test for sterility.
* Tarentula hispana - POISONOUS! Not to be dispensed below 3X.
* Thallium - POISON! Not to be dispensed below 3X.
* Tuberculinum - Handle with care and follow aseptic conditions upto 6X.
* Uranium nitricum - POISON! Not to be dispensed below 3X.
* Vipera torva - POISONOUS! Not to be dispensed below 6X.
* Zincum Cyanatum - Preparations below 6X to be freshly made.
* Zincum Phosphoratum -POISON! Not to be dispensed below 3X.
LABELING is a very important part of the finished product and completes the process of dispensing of the indicated medication. An improperly prepared label can decrease the patient's confidence in the preparation.
The labels on dispensed medicines should -
* Give the patient clear and complete instructions on how to take or use the preparation.
* Indicate the storage conditions necessary to ensure full potency throughout the period of treatment.
* Be neatly written and carefully displayed on the container, thus strengthening the patient's confidence in the preparation.
Labels may be hand written with indelible ink or ready-printed with the name and address of the physician or the pharmacy and, if desired, with certain common directions to the patient. Conventionally, the printing is red for the name of the medication and for labels of external preparations, the association of red with danger, helping to prevent accidental ingestion of the medicine.
The label must not be too small as the information will not be clearly legible. The size of the label should be proportionate to the size of the container.
INFORMATION ON THE LABEL
A. Name of the prescribed medication
The label should carry the name of the medicine with its potency and in case of external preparations, the name and nature of the preparation.
Proper name labeling is recommended for the following reasons - - The patient should be encouraged to understand his treatment.
- It prevents confusion when the patient is receiving different types of medications or medications are prepared for various members of the same family.
- It may be of help to the physician when the prescription of the previous treatment is not available.
Antagonists of this system argue that -
- It may lead to self-medication and misuse of the prescription.
- It may lead to a prejudice on the part of the patient in understanding the treatment.
B. The patient's name
Conventionally, it is written at the right hand side of the label so as to avoid confusion in dispensing by the dispenser and in storage by the patient.
C. The prescription book reference number and date Prescriptions recorded in a prescription book usually carry a serial number for identification. This allows the record to be traced easily if the patient brings the container and not the prescription when a further dose is needed. This is to be followed by the date of dispensing.
D. Directions for use and other information As per the needs, as felt by the physician, the specific directions for intake, usage, storage as well as restrictions of each medicine should be clearly stated on the label.
This also includes the mode of intake and the time of intake of the medicine.
SPECIFIC INSTRUCTIONS
* FOR EXTERNAL USE ONLY
This instruction and caution is essential in all preparations intended for application on the skin. Articles for application to mucous membranes should NOT have this instruction on this label.
* Medications for instillation into the mucous membranes like ear, eyes, rectum, vagina, etc. should have specific instructions as regards their usage.
* SHAKE WELL BEFORE USE This is necessary on all liquid disperse systems. If the dispersed phase separates and the container is not shaken before use, the patient will take low doses of medicament at first and high doses towards the end of the bottle. Several applications like 'shake lotions' are disperse systems and require this label It is needed also on any medicine, in which precipitation or separation could occur on storage like tinctures and syrups.
* STORE IN A COOL PLACE Storage in a cool place, i.e. at not more than 50C may be necessary for certain products like -
Creams: to prevent drying out
Ointments: to prevent loss of water, loss of volatile ingredients and structural breakdown.
Preparations containing volatile ingredients.
* PROTECT FROM LIGHT
This label is necessary when a light-sensitive preparation is packed.
* INFLAMMABLE
When any preparation containing 50 Pecent or more of alcohol or containing another inflammable solvent is dispensed or sold, it should carry the word - 'Inflammable'.
* EXPIRY DATE Depending on the stability of the medication and its storage life, the bottles should carry the expiry date or the storage life (e.g. USE WITHIN 6 MONTHS) on the container. Normally expiration dating is not required for homoeopathic drugs, if their labeling does not bear dosage limitations and they are stable for at least 3 years.
LABELING FOR MANUFACTURED HOMOEOPATHIC PRODUCTS The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any homoeopathic medicine and on every other covering in which the container is packed.
* The words 'HOMOEOPATHIC MEDICINE'.
* The name of the medicine.
* The potency of the homoeopathic medicine. For this purpose the potency shall be expressed either in decimal, centesimal or fifity millesimal scale. Appropriate symbols that are universally accepted and understood, may be mentioned on the label.
* Name and address of the manufacturer when sold in original containers of the manufacturer. In case the homoeopathic medicine is sold in a container other than that of the manufacturer, the name and address of the seller.
* In case the homoeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label. If the homoeopathic medicine contains any other ingredients, then it must be clearly stated on the label.
* No homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label
* The Manufacturing Date of the batch of homoeopathic medicine.
* The Expiry Date of the batch of homoeopathic medicines. This is required in certain preparations. Alternatively, the storage life may be mentioned.
* A distinctive batch number, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection; the figures representing the batch number being preceded by the words 'Batch No.' or 'Batch' or 'Lot No.'. As products are prepared in batches, the batch number helps in tracing out the entire batch in case of defect.
* Manufacturing License Number or 'Mfg. Lic. No.' is the license number of the manufacturer and indicates that the authority granting the license is satisfied with the conditions and that it is competent in manufacturing homoeopathic medicines.
* Instructions for storage and usage.
In addition to complying with the provisions of labelling laid down in the rules the following particulars should be shown on the label for OPHTHALMIC SOLUTIONS. (1) Of the containers (i) The statement 'Use the solution within one month after opening the container'.
(ii) Name and concentration of the preservative, if used.
(iii) The words 'NOT FOR INJECTION'.
(2) Of container or carton or package leaflet (i) Special instructions regarding storage, wherever applicable.
(ii) A cautionary legend reading as "WARNING: (a) If irritation persists or increases, discontinue use and consult physician.
(b) Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate solutions."
PACKAGE INSERTS The difficulty of including on the label of a small container of certain preparations, all the relevant details about the usage and storage of the product has led manufacturers to include 'information leaflet' inside the box enclosing the container of the medication. These can be considered extensions of the label and can include a lot of detailed instructions and information about the medicine.
CAUTION! - as per H.P.I. directions
* Acidum hydrocyanicum - HIGHLY POISONOUS! Handle carefully. All preparations upto 6X should be freshly prepared. Not to be dispensed below 6X.
* Acidum hydrofluoricum - Handle with care as it causes painful sores on the skin usually noticed on the next day only; avoid inhaling the vapors. Not to be dispensed below 4X. Preparations upto 6X to be freshly made.
* Acidum nitromuriaticum - HIGHLY CORROSIVE; Should not be brought in close contact with alcohol.
* Acidum picricum - Explosive when dry, rapidly heated or by percussion. Handle with care. For safety in transportation, it is mixed with 10 - 15 Pecent water. Not to be dispensed below 2X.
* Ammonium aceticum - Preparations below 3X to be freshly prepared.
* Ammonium picricum - VERY EXPLOSIVE; triturations upto 2X should be prepared in small quantities with great care.
* Antimonium chloridum - Not to be dispensed below 3X.
* Apis mellifica - Not to be dispensed below 3X.
* Argentum metallicum - Inhalation of dust should be avoided.
* Arsenicum album - Not to be dispensed below 3X.
* Aviaire - Handle with care and follow aseptic conditions upto 6X.
* Baryta carbonicum - Not to be dispensed below 3X.
* Calcarea caustica - All preparations of this medicine upto 6X should be freshly prepared. Preparations becoming turbid due to carbonic acid should be rejected.
* Iridium metallicum - The drug is non-radioactive and should not be mistaken for radio-active material (Iridium) whose atomic weight is 192. In order to make sure of the non-radio-active material, an appropriate photographic method for testing may be employed.
* Kali cyanatum - Deteriorates with moisture and acid fumes. Not to be dispensed below 6X. DEADLY POISON.
* Kali picricum - An explosive salt; to be prepared with care to avoid explosion. POISON! Not to be dispensed below 3X.
* Lachesis - Not to be dispensed below 6X.
* Medorrhinum - Not to be dispensed below 6X. 6X should be free from live germs and should pass the test for sterility.
* Radium bromatum - RADIOACTIVE; powerful corrosive; effect on skin; Handle with care. POISON! Not to be dispensed below 6X.
* Rhus toxicodendron - POISON! HANDLE WITH CARE; Not to be dispensed below 3X.
* Rhus venenata - The mother tincture poisons the skin. Handle with great care. Not to be dispensed below 3X.
* Shigella dysenteriae - Not to be dispensed below 6X. 6X should be free from live germs and should pass the test for sterility.
* Syphilinum - Not to be dispensed below 6X. 6X should be free from live germ and should pass the test for sterility.
* Tarentula hispana - POISONOUS! Not to be dispensed below 3X.
* Thallium - POISON! Not to be dispensed below 3X.
* Tuberculinum - Handle with care and follow aseptic conditions upto 6X.
* Uranium nitricum - POISON! Not to be dispensed below 3X.
* Vipera torva - POISONOUS! Not to be dispensed below 6X.
* Zincum Cyanatum - Preparations below 6X to be freshly made.
* Zincum Phosphoratum -POISON! Not to be dispensed below 3X.
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