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Questions and Answers
What must separate directions for use be stated for?
What type of information must be included on the label regarding contraindications?
What type of statement must be included on the label for a single-use pharmaceutical product?
What type of interactions must be included on the label?
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What information must be included on the label regarding adverse events?
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What storage information must be included on the label?
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What information must be included on the unit carton?
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What information must be included on the primary label, excluding blisters and foil strips?
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What information must be included on the label regarding the MAH?
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What type of warning statements must be included on the label, as required and/or specified by FDA?
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Study Notes
Labeling of Pharmaceuticals
- Labels and labeling materials are the primary source of information for consumers, providing details on safe and effective use, quality, and manufactures' information.
Label and Labeling Materials
- Label: written, printed, or graphic matter on any pharmaceutical product, providing information on identity, components, ingredients, attributes, directions for use, and specifications.
- Labeling Materials: labels on the immediate container, outer wrapper cartons, package insert/leaflet, and other printed materials accompanying the product.
Label of Dispensed Medicines
- According to RA 10918, Section 36, labels on dispensed medicines should bear the patient's name, generic name of the drug, brand name (if any), strength, expiry date, directions for use, and the name and address of the pharmacy, doctor, and dispensing pharmacist.
White and Red Labels
- White Labels: used for labeling loose capsules and tablets taken orally.
- Red Labels: used for labeling compounded drugs for external use, with a warning notice "For External Use Only".
Auxiliary Labels
- Also known as cautionary and advisory labels or prescription drug warning labels.
- Added to dispensed medication packages by pharmacists to provide supplementary information on safe administration, use, and storage.
Specific Requirements
- Contraindication(s), Precaution(s), Warning(s):
- Labels should contain full information on contraindications, precautions, and warnings.
- Warning statements should be included, as required by FDA (e.g., "For external use only", "Keep out of reach of children").
- Interactions:
- Labels should include drug-drug, drug-food, drug-laboratory testing interactions, and other relevant interactions.
- Undesirable Effects:
- Labels should include detailed information on adverse events for a drug product.
- Overdose and Treatment:
- Labels should include signs and symptoms of overdose, as well as possible treatment.
- Storage Condition(s):
- Labels should indicate appropriate storage conditions and special instructions for handling.
- Pack Size or Net Content:
- Unit cartons should indicate the pack size of the pharmaceutical product.
- Primary labels should indicate the net content of the product in metric units.
- Name and Address of Marketing Authorization Holder:
- Labels should state the name and full address of the MAH for the pharmaceutical product.
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Description
Learn about the importance of labeling in pharmaceuticals, including the information provided and its impact on safe and effective use of pharmaceutical products.
