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“Drug Facts” Labeling Proper Usage Dependant On Consumer Education – FDA

This article was originally published in The Tan Sheet

Executive Summary

While FDA is confident the new "Drug Facts" labeling will help more consumers use nonprescription drugs appropriately, the agency is stressing to an equal extent the importance of educational initiatives in ensuring proper OTC use

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FDA is granting Ricola until Dec. 31 to comply with "Drug Facts" labeling requirements for its 10-count stick of Ricola Natural Herb Cough Drops, according to an Aug. 7 letter to Swiss firm. Ricola requested labeling deferral June 11 due to its "mistaken belief that [FDA] would exempt smaller packages such as its 10-count stick" SKU from the OTC labeling final rule. "Once it became aware" on April 10 the cough drops would not be considered a "convenience-size" package, firm said it began developing new labeling to comply with final reg, but needs additional time to make changes. "Drug Facts" labeling took effect for most OTCs May 16 (1"The Tan Sheet" May 20, 2002, p. 8)...

Ricola labeling deferral

FDA is granting Ricola until Dec. 31 to comply with "Drug Facts" labeling requirements for its 10-count stick of Ricola Natural Herb Cough Drops, according to an Aug. 7 letter to Swiss firm. Ricola requested labeling deferral June 11 due to its "mistaken belief that [FDA] would exempt smaller packages such as its 10-count stick" SKU from the OTC labeling final rule. "Once it became aware" on April 10 the cough drops would not be considered a "convenience-size" package, firm said it began developing new labeling to comply with final reg, but needs additional time to make changes. "Drug Facts" labeling took effect for most OTCs May 16 (1"The Tan Sheet" May 20, 2002, p. 8)...

Ricola labeling deferral

FDA is granting Ricola until Dec. 31 to comply with "Drug Facts" labeling requirements for its 10-count stick of Ricola Natural Herb Cough Drops, according to an Aug. 7 letter to Swiss firm. Ricola requested labeling deferral June 11 due to its "mistaken belief that [FDA] would exempt smaller packages such as its 10-count stick" SKU from the OTC labeling final rule. "Once it became aware" on April 10 the cough drops would not be considered a "convenience-size" package, firm said it began developing new labeling to comply with final reg, but needs additional time to make changes. "Drug Facts" labeling took effect for most OTCs May 16 (1"The Tan Sheet" May 20, 2002, p. 8)...

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