Unit 8: Proper Labelling PDF

Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling Proper Labelling: Pharmaceutical Products and Dispensed Medicine Labels & Labeling Mate...

Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling Proper Labelling: Pharmaceutical Products and Dispensed Medicine Labels & Labeling Materials - Label means a display of written, printed or graphic matter upon immediate container or the wrapper of a drug package A. Manufacturer label The following are the minimum mandatory information that shall appear in the labeling materials - A label which contains drug information for the accompanying a pharmaceutical product: use of medical practitioners, pharmacists, or nurses supplied by the manufacturer, packer, or Display Panels distributor of the drug (FDA). Primary display panel contain the ff information: B. Dispensing label - Name of the product (Generic name alone or - Label that is attached by the pharmacist in with Brand name, as the case may be dispensed medicine not packaged in original - Dosage form and strength, container. - Pharmacologic category - Rx symbol, in case of prescription drugs. Sd: reason why we attach dispensing label: 1.) when - Name and complete address of manufacturer pharmacists perform extemporaneous compounding, and trader, when applicable 2.) when product is dispensed in another container. - Net content It is the primary source of information for Information panel/side panel contain information not consumers. found in the primary display panel. It provides useful information such as: - Expiration and Manufacturing Date, Indications - Those dealing with the safe and effective use of - Other information is found in product insert. a pharmaceutical product (e.g., indication(s), pharmacologic class and dosage) - information dealing with quality (e.g., manufacturing and expiration dates, registration number, and manufacturer). The Food and Drug Administration (FDA), as the regulatory authority of the Philippines responsible for all matters pertaining to pharmaceutical products, has crafted several issuances to ensure that drug establishments provide the most accurate information relating to their products. A.O. No. 55 Requirements for labelling materials of Pharmaceutical Products. FDA Administrative Order 2016-0008 “Revised Rules and Regulations Governing the Generic Labeling Requirements of Drug Products for Human Use” Primary Packaging: Bottle Secondary Packaging: Box/Carton  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling Insert and Leaflet Package Insert (PI) - the document defining information that is supplied with prescription drug products by the MAH. The PI is intended for use by healthcare professionals. Patient Information Leaflet (PL) - the document defining information that is supplied with non- prescription drug products by the MAH. The PIL is IF with multiple AI: intended for use by patients and is written in layman's - INDICATED WITHIN THE BOX language. - Separated using (+) symbol General Requirements - Enumerated in order of decreasing Pharmacologic Activity All information required to appear on the label must be: - If more or less have same pharmacologic activity, enumerated in order of decreasing potency & strength. IF there is single name of fixed dose combination approved by FDA: - Single approved name should be used: - Ex: Sulfamethoxazole + Trimethoprim= Cotrimoxazole - Amoxicillin + Clavulanic acid= Co-amoxiclav Product Name If there is no single name approved but with generic class name - Generic (required) & Brand name (if any) must be indicated - Generic class name shall be used. The - GENERIC NAME: Printed in full & appear components is enumerated in the formulation. prominently inside an outline box. - Not abbreviated - In accordance with INN (international non- proprietary name) w/ salt/ chemical form = needs to be indicated; included inside the box BUT in a smaller point Dosage Form and Drug Delivery For Herbal Medicines - Drug delivery refers to the technology utilized A.O. 172 s. 2004 to present the drug to the desired body site for - name should be the botanical origin approved drug release and absorption by FDA. - Ex: Modified release, Extended release, - Specific plant part(s) used shall be stated after Chewable the common name. - Dosage forms, also known as routes of - Should contain Scientific Name, Common administration describe the physical form in Name and Plant Part Used. which medication will be delivered into the body. IF WITH BRAND NAME: - Ex: Tablets, Capsules, Solutions - GN should be inside the box and appear Both dosage form and drug delivery system must above the BN. be indicated. - GN & BN = same typeface, font/ color - GN font size bigger than the BN Reason? IF BRAND NAME PRESENTED ON SPECIAL - Chewable tablet – to inform the patient the TYPEFACE: tablet chewed first before swallowing - GN – Helvetica Medium or Universe Medium  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling - Vaginal tablet – to inform the patient that the - The indication(s) stated in the labeling materials tablet is inserted into vaginal orifice and not shall include only the FDA-approved clinical swallowed. use(s) of the pharmaceutical product. - “Off-label use" means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert. Example: Diphenhydramine - Pharmacologic category: Antihistamine Dosage Strength - FDA approved use: Allergic reaction Dosage strength – concentration or potency of the API. - Off label use: Chemotherapy- Must be expressed in Metric units and in the number of induced emesis / OTC sleeping the largest unit specified (ex: 500mcg not 0.5mg) aid (not used for chronic insomnia) Unit of Measurement Standard Measurement Metric (most commonly Volume – liter used) Weight – gram Formulation/ Composition Apothecaries System Volume – Minims (Traditional system of Formulation - the name, strength, and reference Weight – Grains pharmacy) monograph of all APIs and/or excipients present in the Widely used in USA in drug product. measuring body weight Avoirdupois System Active ingredient stated in Generic Names and in selling goods by ounce or pounds (International Nonproprietary Name - INN) Amounts in metric system FDA allow the expression of dosage strength in Salt must be stated (can be abbreviated, ex: percentage (%) as deemed necessary and appropriate. Diphenhydramine HCl) (Ex: Alcohol) Multiple components enumerated in order of For products with multiple active ingredient w/o decreasing pharmacologic activity single approved name = individual strength must be Coloring agent/ excipients used – may indicated separated by (/) stroke or slash symbol. cause hypersensitivity/ ADRs must be indicated For products with multiple active ingredient w/ single Alcohol content = (%). The term alcohol approved name = One dosage strength is indicated without qualification means ethyl alcohol Note: Excipients are not required to be indicated unless it can cause hypersensitivity or ADR since it is a trade secret. Indication & Pharmacologic classification Dosage and Mode of Administration Pharmacologic category – refers to the classification of the drug product based on its therapeutic action as Dosage - the quantity of a medicine given per specified in the product registration. (Placed in primary administration. panel) Mode of Administration - the manner and site where Sd: Classification based on its Mechanism of Action the drug product is to be introduced (MOA), how it takes affect on the body. Label shall contain full info on products: Indication – the FDA-approved clinical use of a drug - Loading dose/ initial dose – also the priming, is product based on substantial, scientifically supported the amount required to attain the desired evidence of its safety and efficacy in the given dosage concentration of the drug in the blood or tissues form. (Placed in side panel/product insert)  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling - Optimal use dose/ usual dose – the amount Precautions that may be expected to produce, in adults, the medicinal effect for which it is intended - refers to the instruction and special care required - Frequency in the used of the product to avoid undesired - Duration of tx effects and to ensure the safe and effective use of - Dosage adjustment (if any) the drug. Also contains relevant information such as: Contraindications, warnings & precautions shall be indicated and with full information. - Info on dilution, reconstitution, preparation or administration must be included. If the drug is to be used on one occasion only, any of the - “Shake well before use”- suspension following statement must appear: - “Do not crush”- tablets - “Single Use Only” Dosage for Special Population: - “Single Dose” - “Use only once” Separate direction for adults and children must be stated; - “Discard any remaining portion” if Not recommended for children - ADULT DOSE Interactions, Adverse Drug Reactions, Special Populations: Overdose and Treatment - Geriatrics Adverse Drug Reaction (ADR) – a response to a - Pediatrics medicine that is noxious and unintended, and which - Pregnant occurs at doses normally used in man. Toxicity – It happens during excessive intake of a certain medication. - The label shall include drug-drug, drug-food, drug-laboratory testing interactions, as well as other relevant interactions, if applicable. - The label shall include detailed information on adverse drug reaction(s) for a drug product arranged by system organ class. - The label shall include signs and symptoms of overdose, as well as possible treatment. Information on Dosage and Mode of Storage Condition Administration is placed in the side panel or in Storage condition – the acceptable specified the package insert. temperature range, humidity, and other environmental factors within which optimal stability of the drug product is ensured based on laboratory data. Contraindications, Precautions and (a) Label should indicate appropriate storage Warnings condition and special instructions for handling. Contraindications Normal storage conditions - refers to statements regarding the conditions - Storage in dry, well-ventilated premises at wherein the use of the product may cause harm temperatures of 15–25°C to the patient - or, depending on climatic conditions, up to 30°C. Warnings Defined storage instructions - It refers to statements regarding the occurrence - Drug products that must be stored under defined of potential hazards and side effects associated conditions require appropriate storage with the use of the product and the limitation of its instructions. use. - Ex: continuous maintenance of cold storage, deviation may be tolerated only during short- term  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling interruptions, for example, during local Primary label excluding blister packs and foil strips transportation. - State the total amount/qty/number of the dosage (b) Special storage instructions for products with the form in a given container and expressed in metric following characteristics: units. - Ex: 60ml (for liquids) 5g (for sachets) 100 sachets Common terms: - Freezer between (-) 25°C and (-)10°C - Cold temperature: not exceeding 8°C - Refrigerator thermostatically controlled between 2°C and 8°C - Cool temperature – between 8°C and 15°C - Controlled room temperature – thermostatically 4.1 grams controlled between 20°C and 25°C with allowed excursions between 15°C to 30°C. “Protect from moisture” no more than 60% relative humidity in normal storage conditions; to be provided to the patient in a moisture resistant container. “Protect from light” to be provided to the patient in a light-resistant container. Pack size/ Net Content Name and Address of MAH and Pack Size – refers to the quantity of dosage form in the Manufacturer final packaging (excluding the shipping carton) of a drug product bearing the required labeling information. Marketing Authorization Holder (MAH) Net Content – the total amount/quantity/number of the - the company or corporate or legal entity in the dosage form in a certain container of a drug product field of pharmaceuticals in whose name the MA expressed in metric system. for a drug product has been granted. - In the Philippines, the MAH may either be a Unit carton – Indicate the pack size of the pharmaceutical manufacturer or distributor (exporter, importer or product expressed in terms of: wholesaler) of pharmaceutical products. - No. of units in the pack (ex: 500 tablets, 10 blister (a) The label shall state the name and full address of the packs x 10 tablets) MAH of the drug product. - Volume of each unit (ex: 60ml, 120ml) - Products for reconstitution = pack size shall reflect (b) The label shall state the name of the manufacturer and the volume of the product as reconstituted full address of the specific manufacturing site of the drug product as determined by FDA.  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling Rx Symbol - Printed in a contrasting color with the background - Overprinting/ superimposition of Rx is allowed provided that it will not result in obliterating / rendering less legible other required label requirements. (basta hindi matakpan yung ibang important information) - Printed not less than 1/5 of the height of PDP CAUTIONARY STATEMENT: For Rx products: “Foods, Drugs and Devices and Both herbal medicines and Cosmetics Act prohibits dispensing without prescription” dietary supplements are regulated by the FDA. To know For Dangerous drugs: “Foods, Drugs and Devices and if it is FDA registered: Cosmetics Act prohibits dispensing without prescription as specified by PDEA” For herbal medicines: HMRxxxx For dietary supplements: FRxxxxxxx Batch and Lot Number Batch & Lot Num. – both are identification number. ADR Reporting Statement Batch – a defined quantity of starting material, packaging material or product manufactured in a single or series of In unit carton, primary Label and product Information processes so that it can be expected to be homogeneous. sheet “Product quantity that is produced or processed in a - This statement shall appear: “For suspected single manufacturing run” adverse drug reaction, report to the FDA: www.fda.gov.ph.” Lot Number – any distinctive combination of letters and/or - Not required to appear in: blister pack, foil strip, numbers assigned to a particular lot, herein defined as a and small containers of products intended to be portion of a batch. sold without a unit carton. “Product quantity that is not necessarily from a single In addition: production batch” - A statement instructing the patient to seek The label shall indicate: medical attention immediately at the first sign of any adverse drug reaction. - Product’s batch number = if entire batch is - In addition, the company may include a reporting marketed by one drug establishment. statement for their own pharmacovigilance - Product’s batch and lot number = drug is system. marketed by different drug establishments. Registration Number It is usually place in information panel. If the drug is in blister package = Batch/ Lot no. – printed Registration number – a combination of letters and/or numbers assigned to a particular drug product by FDA as on each strip of 10 blister units. proof of registration. Sd: if blister package siya iisa lang ang batch/lot no. na nakaprint sa isang blister pack (banig) The label shall indicate the registration number assigned by FDA to the product, which is denoted by a combination of letters and/or numbers.  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling Manufacturing and Expiration Date Products for External Use The label must indicate the month and year of For products intended to be applied externally (creams, manufacturing and expiration date. If the day is specified, ointments, pastes, liniments (embrocation) etc.), this the month should be spelled out. statement must appear in the label: Following this format: “For external use only” June 2020 or Jun 2020 06/2020 03 June 2020 or 03 Jun 2020 If there is no specified date, the last day of the stated month shall be the expiration date of the product. Printed or embossed in tin foil/ blister/ strip package = printed on each strip. For reconstituted drug, a period of guaranteed efficacy must be specified at a given storage condition. Biological Products Biological products – Any product of biological origin, prepared with biological processes, derived from human blood and plasma, or manufactured by biotechnology, consisting of substances of higher molecular weight Parenteral Products whose purity, potency, and composition cannot readily For parenteral products, the following additional and reliably be determined by chemical or information shall be required: physicochemical analysis. a) A statement of the recommended mode of Ex: administration such as "IV", “IM” or "SC", etc., as A. Vaccine the case may be. B. Gene therapy b) When antimicrobial agent not included: “Use only C. allergenic extracts once or discard any remaining portion” D. blood products for transfusion c) If Contents only to be used in 1 occasion: “Single use or Single dose” (a) The name of the species of animal or organism from d) For concentrated solution for injection: “Do not which the product has been prepared. administer undiluted or dilute the solution with the specified diluent to appropriate volume before (b) The name of any adjuvant in the product or any use.” substance which, when administered with an antigen, modifies the immune response to that antigen.  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling Multivitamin/ Mineral/ Herbal Products with Physician’s Sample & Drugs under MDRP Non-vitamin/ Mineral/ Herbal Components (a) In addition to the minimum requirements, each a) The generic name adopted for multivitamin-containing individual dosage unit of the physician's sample shall products shall be "Multivitamins"; for multi-mineral- include batch and or lot numbers, date of manufacture and containing products the official name shall be "Minerals". expiration date. (b) On each of the labeling material(s), the following statement, shall appear in red background or red font: Stresstabs contains more than three (3) vitamins hence Physician’s Sample Not For Sale multivitamins and one mineral or which is iron. Physician’s Sample Not For Sale Centrum advance contains more MDRP – Maximum drug retail price than three (3) vitamins and minerals The following statement shall be required to appear in red hence the generic name is background. (drugs for hypertension diabetes and lung Multivitamins + Minerals diseases) ImmunPro only contains Ascorbic acid (as sodium ascorbate) and zinc therefore multivitamins +minerals should not be used. Sd: the President has the power to freeze the prices of basic and prime commodities in the PH which also b) For multivitamin and/or multi-mineral preparations includes the drug. containing at least three herbal ingredients, the generic class name of the herbal ingredients shall be "Herbs". Isang drug na nafreeze ang prices sa market dahil widespread ang illegal price manipulation and nasa state c) The unit content of each vitamin, mineral, and/or herbal of emergency ang PH is called the MDRP. ingredient present shall no longer be required to be indicated in the generic box, but rather shall be reflected Reproductive Health Products under Formulation. - OCP – oral contraceptive pills - The product information for reproductive health (RH) products that are drugs shall include both PI and PIL. - The PIL shall be written in English and Filipino, and/or local dialect. Pharmaton only contains one herb which is Ginseng extract therefore the term “Herbs” in the generic name is not used. Small Containers Has capacity of 10 ml or less; container is enclosed on primary pack Example: Ampule and Vials The primary label of small containers shall contain the following minimum information: 1) Product name 2) Dosage Form and Strength 3) Net Content 4) Name and or Logo of Marketing Authorization Holder 5) Rx Symbol (if applicable)  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling 6) Registration Number 7) Storage Condition(s) 8) Batch and or Lot Number (if any) 9) Expiration Date and Date of Manufacture Due consideration may be given in view of limited space on the label. Exemptions: FDA Administrative Order 2016-0008 The following are NOT required to follow these regulations: What is a Barcode? Why it is important? 1. Container or primary pack containing products enclosed in transparent covering which are required to be set out on Barcodes/ Symbology – the pattern represented in a bar the label on the container or the primary pack are clearly code that encode data and allow it to be converted into visible through the transparent covering information with the use of scanner or imager. 2. Products compounded by the pharmacist in accordance Importance: with the Rx 1. One of the most proven and effective methods to 3. Products used solely for investigational use prevent medical errors. 4. Products donated by foreign agencies, requirements on 2. Identify medications at the unit-dose level for dispensing generic labeling may be waived except that the expiry date and administration. must be indicated (Ex. COVID vaccines) 3. It useful if the pharmacy is already using automated Dispensing Labels dispensing system. ADS rely on bar coded medications and cassettes for their automatic medication selection and These are labels that are attached by the pharmacist in counting processes. dispensed medicine (bottle, box, packaged) not packaged in original container or in extemporaneously compounded 4. It is a legal requirement: FDA Circular No. 2014-011 medication. FDA Circular No. 2014-011 As per RA. 10918, upon every box, bottle, or package of Adoption of Unique Global Product Identification medicines compounded or dispensed by a registered and Number licensed pharmacist based on prescription, there shall be pasted, affixed, or imprinted a seal or label bearing: A policy mandating barcoding system on all medicine and health products has been issued by the Philippines' Food the name of patient and Drug Administration (FDA) as a means to ensure generic name of drug and brand name (if any) patient and consumer safety strength expiry date The identification numbers are part of widely used supply directions for use chain standards system recognized by the World Customs and name and address of pharmacy Organization and the World Health Organization. name of the doctor, the dispensing pharmacist The exterior of the product (i.e. packaging, labels, Even without dispensing label: and/or containers) as presented to consumers must bear the product identification number and/or its equivalent 1. drugs intended for Cardio Pulmonary identification graphic. Resuscitation (CPR) Emergency. 2. Other emergency situations when the medicine dispensed is to be administered immediately. In addition to the information required by law, it is recommended that the following information also be 1. Labeler Code/Manufacturer’s Code provided on the prescription label. 2. Product Code – identifies the product, in terms of the name, strength and dose formulation 1. Number of dosage units or volume of product 3. Package Code – identifies what is the package dispensed size and package type of the said product 2. Number of refills allowed 3. Barcodes (recommended but not mandated)  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling → comes directly from the GS1 Two symbologies used in healthcare: Philippines (Global System for Supply Chain Standards) 1. Aztec – able to contain 13-3000 numeric characters Types of Symbology found in Products: 2. Data matrix – not used by manufacturers, but common in medication administration. Linear Symbology – One dimensional format. This 3. QR code/ Quick response code – most contains series of black and white lines and spaces of commonly used in marketing purposes. It can varying thickness and distance between the lines. direct the consumer to the manufacturers website or promotional ad and customer hotline. 1. UPC 2. Code 39 3. Code 128 4. GSI-128 5. GS1 Databar (1) UPC (universal product code) – one of the first linear symbology to be used commercially, and which is used routinely in the grocery industry. This consists of a prefix digit and check digit. Prefix digit no. 3 = Pharmaceutical Products (2) Code 39 – most commonly used symbology for health Guidelines for Dispensing Labels care products. This symbology is rather long and therefore 1. Indicate the dosage form to be administered. difficult to use on small packages. - e.g. "Take one tablet every day." instead of "Take one every day." 2. Use words instead of numbers. - e.g. "Take one tablet every day" instead of "Take (3) Code 128 – Compressed code 39. for small packages 1 tablet every day.” of medication 3. 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 (4) GSI-128 – for products that may be packaged or volume, such as 2.0 ml, be administered. shipped in different units. Ex: intravenous fluids, which - In such a case, the pharmacist should provide a have individual bags shipped in a case of six or twelve properly calibrated measuring device along with units the medication. (5) GS1 Databar – most widely used by manufacturers 4. Specify the route of administration if the medication is not intended for oral use. - e.g. Insert one suppository vaginally every night at bedtime. - Vaginal = pessaries, Urethral/ nose = bougies, Ears = aurinaries 5. Do not use abbreviations. 2D Symbology - Instead of lines and spaces, this type of symbology uses small dots or lines arranged in an order - e.g. "Take two capsules twice a day." not "Take using the horizontal and vertical axes. Omni directional. two caps twice a day."  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling 6. Specify all active ingredients in a compounded (3) Potential interactions with other medicines prescription. - The problem can be avoided by giving - Inert bases or vehicles may, but need not, be incompatible preparations 2hrs apart. labeled. 7. Assign BUD (compounded prescription) & storage condition. 8. Attach auxiliary labels - This contains the warning, reminders, side (4) Cautions in use effects, and instructions of the chosen drug. The - Avoid exposure of skin to direct sunlight other term for this label is cautionary and - Ex: Tetracycline (Doxycycline)& advisory label (special instructions). Fluoroquinolones (Ciprofloxacin) - These are used to reinforce the information discussed by the pharmacist during counseling - This preparation may color the urine or stools that the patient needs to know. (Note: This is not - Ex: Rifampicin (It can turn body fluids into red a substitute for patient counseling) orange) Auxiliary label should be: Evidence-based Should not cover the primary display panel In simple explicit language - Be minimized to avoid distracting patients with nonessential information - Most patients (especially the ones with limited literacy), pay little attention to auxiliary information Example Cautionary Labels: (1) Drowsiness warnings Drowsiness, dizziness, blurred vision or difficulty in concentrating - Some medicines make patient more drowsy esp. when consuming alcohol - Hypnotics used as sleep aids taken at bedtime may cause drowsiness persisting next day - Ex: Antihistamine, Sedative & Hypnotics (2) Potential interactions with food or drink - Drugs that decreases absorption when taken with food. (Ex: Tetracycline + Dairy Products= dec abs of Tetracycline) - Better absorption with food (Ex: Griseofulvin + Fatty foods = inc abs of Griseofulvin) - Some medicines have improved absorption without food (oral antibiotics)  Dispensing 1 (Dispensing Process, Reading & Interpreting the Prescription and other Medicine Orders) (PDIS211) Parinas, G.I. Unit 8: Proper Labelling Example Special Instruction Labels Enteric Coated – cannot be split into half because it should be release in the stomach Crushing the tablets - Reason: economical reasons. - Can all tablet be crushed? No. Only tablets that are scored or grooved. Pharmacist should advise the patients the following: 1. Verify if tablets can be safely split 2. Suggest devices for tablet splitting 3. One tablet at time crushing – It can be affected by humidity and heat. White and Red Labels White Labels are used to label compounded drugs which are taken orally. Ex: Paper tablets Red Labels are used to label compounded drugs which The labels must have a warning notice are externally used. "Warning: For External Use Only" to avoid confusion Compounded drugs such as ointments, creams, lotion and misuse. and others are examples.