REQUIRED BY LAW:
1. For External Use Only : This along with the description of the product e.g, The liniment, The Lotion , is required in the case of liquid medicines for external (Skin) Application.
2. Not To Be Taken: This is used if the liquid is a preparation other than medicines and is contained in a bottle of not more than 3 liters capacity e.g, Antiseptic and Disinfectant Solutions.
INSTRUCTIONS RESTRICTING USE OF PREPARATION
1. For External Use Only: It is accepted Pharmaceutical practice to use this label on every product which is not meant to be swallowed by mouth.
2. Not To Be Taken: It is used for:
a. Liquid preparations that are not used by mouth
b. Liquid preparations that are used on skin
c. Liquid preparations on which the label “For External Use Only” might confuse the patient.
d. Unit Dosage forms not intended for oral use; e.g, pessaries and suppositories.
For cases like (c) and (d), One possibility is “Not to be taken by mouth” but this is not entirely satisfactory for nasal sprays and drops, another is to use precise although not elegant wordings such as: “For Nasal Use Only” for Nasal Sprays and Drops and “For Rectal Use Only” for Enemas and Suppositories.
e. Solution Tablets, used to prepare antiseptic and disinfectant solutions.
INSTRUCTIONS FOR USING THE PREPARATION
1. Shake Well Before Use:
a. This is necessary on all liquid heterogeneous dispersion systems such as suspensions and emulsions
b. Several Applications, liniments and lotions are suspensions and need this label
c. It is also needed on any medicine in which precipitation or separation may occur on storage, e.g, mixtures containing vegetable extracts such as tinctures
2. Special Instructions:
i- Dusting Powders: “Not to be Applied to Open Wounds or to Raw or Weeping Surfaces”
ii- Enemas: “To be Warmed to Body Temperature Before Use”
iii- Gargles and Mouth Washes: “Not to be Swallowed in Large Quantities”
iv- Inhalations: “Add One Teaspoonful to a Pint of Hot, not Boiling, Water and inhale the vapors ”
v- Insufflations and Sprays: “To Be Used in a Suitable Atomizer as Directed”
vi- Linctuses: “To Be Sipped and Swallowed Slowly Without The Addition of Water”
vii- Mixtures for Adults: Adult mixtures are always diluted unless the prescriber directs otherwise
viii- Mixture for Children: Give directions to dilute before use or use undiluted, as the case may be.
· Chewable Tablets: like CaCO3, Ca-Gluconate, Compound Mg-Trisilicate tablets. “To Be Chewed Before Swallowing”
· Sublingual Tablets: Like Glyceryl Trinitrate and Oxytocin Tablets, “To Be Swallowed Slowly in the Mouth/Beneath the Tongue”
· Effervescent Tablets and KCl Tablets: “To Be Dissolved in Water Before Swallowing”
INDIVIDUAL PREPARATIONS TO WHICH SPECIAL INSTRUCTIONS ARE RELEVANT
Watch must be kept for directions peculiar to a particular preparation. For example:
· The Warning relevant to Phenol Ear Drops, that “Dilution with Water Renders These Drops Caustic”
· Warning applicable to Podophyllum Paint and Dithranol Paste, that “The Preparation is Very Irritant to the Eyes and Tender Parts of the Skin”
· Warning applicable to Antibiotic especially Tetracycline containing preparations, that “Do Not Take With Milk or With Full Stomach”
INSTRUCTIONS INDICATING STORAGE CONDITIONS AND SHELF LIFE
1. Store in a Cool and Dry Place:
· Capsules: Loss of moisture makes the shells brittle
· Creams: To prevent drying out
· Collodions and Paints: They contain volatile solvent
· Emulsions: High temperature may encourage creaming
· Ointments: To prevent loss of water, volatile ingredients and structural breakdown
· Moulded Suppositories and Pessaries: Prevent melting at room temperature or below
· Preparations containing Thermolabile Medicaments: To prevent loss of potency
· Preparations containing Volatile Ingredients:
2. Protect From Light:
3. Inflammable: The RPSGB has made following recommendations:-
a. When scalp lotions and shampoos containing 50% or more of alcohol or containing a more inflammable solvent, either alone or in combination, are dispensed, they should be labeled “Caution, this Product is inflammable. Do not use it or Dry the Hair near a Fire or Naked Flame”
b. When any other preparation containing 50% or more of alcohol, or containing another inflammable solvent, is dispensed or sold, it should carry the word “Inflammable”
4. Expiry Date:
5. Protection From Children: All dispensed medicines should carry “Keep Away From the Reach of Children”
Patients under treatment with certain drugs may have serious reactions, if they take particular food or take certain other drugs. The RPSGB recommends that warning cards should be issued to such patients. Two available types are:
a. MAOI Cards: These cards enlists the amine containing foods, because Amine rich foods should not be eaten by patients taking Mono Amine Oxidase Inhibitors (Antidepressants)
b. Aspirin Cards: These advice patients to seek Pharmacist’s advice whenever the purchase of a proprietary medicine is contemplated as Aspirin containing preparations should be avoided completely by patients under treatment with Coumarin Anticoagulants, Oral Antidiabetics, the Anti-neoplastic drugs and Methotrexate.
It is also suggested that drugs for which these warnings are necessary should be segregated and the shelf labeled with a reminder to issue the appropriate warning card.
Normally there is only one package insert for the medicines, but it is recommended that there should be two package inserts for the pharmaceutical products
a. For Prescriber/Pharmacist: Should contain each and every detail of the product including ingredients, Use, Directions for use, and Pharmacology.
b. For Patients: Should contain in simple language:-
· The dose related to meal times or symptoms
· The method of Use of Local applications such as Nasal Sprays and Atomizers.