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In Most Consumers' OTC Pain Relief Decisions, Safety Missing As A Factor

Executive Summary

Most US consumers choose pain relievers based on speed and efficacy instead of factors critical to safe use – age, health conditions and use of other OTCs and drugs – according to a survey supported by J&J/McNeil.

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Judge Rejects Prior Restraint For Tylenol Ads Ahead Of 'Bellwether' Trial

J&J/McNeil may continue to advertise the Tylenol line ahead of the first case in multi-district litigation claiming use of the products as labeled is linked to liver damage, says a federal judge. The plaintiff asked the court to prohibit the firm from advertising that could taint the juror pool ahead of the fall trial.

OTC Antacid/Aspirin Bleeding Risk Raises Concerns At CDER

CDER publishes a Drug Safety Communication, a consumer announcement and a MedWatch notice warning about the risk of serious bleeding when using OTC aspirin-containing antacid products.

OTC Acetaminophen Label Guidance For Liver Warning Clarifies Ingredient Specifics

FDA allows marketers of acetaminophen-containing OTC products to use an alternative liver warning, according to an updated guidance. The change from the draft, which aligns with a request by CHPA, separates maximum dosage for the ingredient from the dosage included in a certain product.

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