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Labeling OTC Human Drug Products

Labeling OTC Human Drug Products 2025

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The document provides guidance from the FDA on labeling over-the-counter (OTC) human drug products using a column format. It outlines standardized content and format requirements to enhance readability and consumer understanding of OTC drug labels. The guidance details how to effectively use multiple Drug Facts boxes, including recommendations for layout, titles, visual graphics, and the organization of information to ensure compliance with regulations.

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Which of the following information must be included in OTC drug labeling except?

Explanation: All of the following are required on an OTC medication label except the NDC number. OTC medications, which are drugs that do not require a prescription, have specific labeling requirements set by the FDA.

What is a human OTC drug?

Over-the-counter (OTC) medicines are those that can be sold directly to people without a prescription. OTC medicines treat a variety of illnesses and their symptoms, including pain, coughs and colds, diarrhea, constipation, acne, and others.

What are OTC drugs?

WHAT IS THE MOST COMMONLY USED OTC MEDICATION? The most commonly used over-the-counter medications include: Pain relievers such as acetaminophen, aspirin, ibuprofen and naproxen. Medicines for heartburn and indigestion such as omeprazole, lansoprazole, cimetidine, and aluminum hydroxide.

What is the meaning of human OTC drugs?

Medicines you can buy without a prescription are called non-prescription or over-the-counter (OTC) medicines. They may be taken to treat minor health problems at home. Examples of over-the-counter medicines are acetaminophen, aspirin, antacids, decongestants, antihistamines, and laxatives.

What are the labeling requirements for OTC products?

The Over-the-Counter Drug Facts Label Active Ingredient(s) Active Ingredient(s). The substance(s) in the product that cause the intended therapeutic effect. Purpose(s) Purpose(s). Use(s) Use(s). Warning(s) Warning(s). Directions. Directions. Inactive Ingredients. Inactive Ingredients. Other Information. Other Information.

What sodium level does an OTC drug not need labeling?

(a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per dosage unit (e.g., tablet, teaspoonful) if the sodium content of a single maximum recommended dose of the product (which may be one or more dosage units) is 5 milligrams or more.

Labeling OTC Human Drug Products 2025

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