Report Side Effects Label

Product SKU: 2101

  • Available 1,000 per package.
  • Label reads: “Call Your Doctor for Medical Advice About Side Effects. You May Report Side Effects to FDA at 1-800-FDA-1088”
  • The FDA proposes (and will be requiring) that its toll-free MedWatch phone number be placed on certain Rx and OTC drugs so consumers can call the agency to report adverse drug events (ADEs). This label provides a quick and easy solution!
  • Pharmacists can apply this label to medications to relay appropriate information to patients.
  • Affected would be pharmacists, who would have to provide this information as they dispense new and refill drugs to consumers, and manufacturers, who would have to add the statement in their medication guides or OTC labeling.
  • This rule, published in the April 22 Federal Register, would bring its regulations into compliance with the provisions of the Best Pharmaceuticals for Children Act.
  • The FDA proposes that after this rule is finalized, pharmacies and manufacturers would have not more than one year to meet its requirements.
  • Labels are White with Black print.
  • Packaged in blister packs for use in label dispensers.
  • Dimensions: 1-5/8″W x 3/8″H (41mm x 10mm)

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