What Is a drug Facts label?

What Is a drug Facts label?

Every over-the-counter (OTC) medicine you can buy at the store must include a ‘drug facts’ label. This label has information about what the medicine does and how to use it safely.

Is drug Facts label required?

Drug Facts labeling requires, among other things, a description of the active ingredients and their purpose, the product’s uses, warnings, directions, other information, and inactive ingredients.

What must be included on a medicine label?

All prescription medicine containers include information on the label including the patient’s name, the name of the medicine, dosage and instructions on how often to take the medicine. More detailed printed information about the medication is usually provided by the pharmacy when prescription medicine is dispensed.

What is a FDA label?

Specifically: Section 201(k) defines ‘label’ as a: ‘display of written, printed, or graphic matter upon the immediate container of any article…’ The term ‘immediate container’ does not include package liners.

Does FDA require barcode?

FDA regulations require that certain human drug and biological product labels contain a bar code consisting of, at a minimum, the National Drug Code (NDC) number (21 CFR 201.25). This guidance provides questions and answers relating to how the bar code label requirements apply to specific products or circumstances.

What are the 5 parts of the Drug Facts label?

OTC Drug Facts Label

  • The product’s active ingredients, including the amount in each dosage unit.
  • The purpose of the product.
  • The uses (indications) for the product.
  • Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist.

What does FDA stand for?

Food and Drug Administration
Food and Drug Administration/Full name

Are OTC FDA approved?

OTC drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. FDA’s review of OTC drugs is primarily handled by CDER’s Office of Nonprescription Drugs.

Can you take too much sodium citrate?

Serious side effects of citric acid and sodium citrate include muscle twitching or cramps, swelling or weight gain, weakness, mood changes, rapid and shallow breathing, fast heart rate, restless feeling, black or bloody stools, severe diarrhea, or seizure (convulsions).

What are the 5 parts of the drug Facts label?