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What are the 7 parts of a drug label?

Overview Highlights of Prescribing Information. Section 1: Indications and Usage. Section 2: Dosage and Administration. Section 3: Dosage Forms and Strengths. Section 4: Contraindications. Section 5: Warnings and Precautions. Section 6: Adverse Reactions. Section 7: Drug Interactions.

What are 7 items that must be on OTC medication labels?

Below is an example of what the OTC medicine label looks like. Active Ingredient. Therapeutic substance in product; amount of active ingredient per unit. Uses. Symptoms or diseases the product will treat or prevent. Warnings. Inactive Ingredients. Purpose. Directions. Other Information.

When taking an OTC drug you should read the label for?

The label tells you what the medicine is supposed to do, who should or shouldnt take it, and how to use it. The labeling of OTC medicines has always contained usage and safety information for consumers.

Who regulates OTC labeling?

I. OTC Drug Product Labeling. This information collection supports implementation of general drug labeling provisions, including certain OTC drug product labeling requirements found in FDA regulations in 21 CFR part 201 and in section 502(x) of the Federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C.

Who regulates OTC drug labeling?

The Food and Drug Administration (FDA), under the Federal Food, Drug, and Cosmetic Act (FFDCA), regulates the safety and effectiveness of nonprescription (over-the-counter, or OTC) drugs sold in the United States. To market an OTC drug, a company may follow one of two pathways.

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Which of the following information is required on an OTC medication label?

All over-the-counter (OTC) medication labels contain Drug Facts. Drug Facts include important information about the active ingredient(s), uses, warnings, doses, and directions.

What are the labeling requirements for over-the-counter drug?

All OTC drug labels include Drug Facts, the who, what, how, when, and why of that medicine. The Drug Facts tell you what you need to know to give the right drug, in the rightdose, to the right person, at the right time, in the right way, and for the right purpose.

What is required for all OTC drugs?

Drug products can be marketed without a prescription (i.e., nonprescription) or over-the-counter (OTC) if the Food and Drug Administration (FDA) determines they are safe and effective for use by a consumer without supervision by a licensed health care professional. have a low potential for misuse and abuse.

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