When you see the words “Maximum Strength” plastered on a container of over-the-counter medicine, you most likely assume that the drug contains the highest dose that you can buy without a prescription, or the maximum dose that a person can take in one day. “Maximum strength” really has no fixed meaning, and that’s what has led to a dispute between two companies that make anti-flatulence medications.

The National Advertising Division is part of the national Council of Better Business Bureaus, and they’re a self-regulation body for the advertising industry. Companies can file complaints against each other, which the NAD investigates objectively. This is a less painful process than having a complaint filed against an ad with the Federal Trade Commission. It isn’t legally binding, but companies generally follow the NAD’s recommendations.

In this case, Novartis, the maker of Gas-X, complained about a new competitor on the national-brand simethicone market, DulcoGas. Specifically, they objected to the “Maximum Strength” label on the product, which consumers could interpret to mean that it’s the strongest simethicone tablet on the market.

The NAD evaluated these claims and saw two possible interpretations: that DulcoGas is the strongest pill available, or that the recommended dose is the maximum amount of the drug that a person should take per day. Neither is true: Gas-X sells an “extra strength” version at the same doze, 125 mg, and there are pills at higher doses available. The maximum recommended dose per day is 500 mg, which hasn’t changed since the FDA published regulations for anti-gas medications in 1974. The packaging for simethicone products tells adults not to take more than four pills (500 mg) in one 24-hour period. One pill, however, doesn’t contain the maximum dose.

Terms like “maximum strength” and “extra strength” might be plastered on bottles and boxes of non-prescription medication, but they aren’t regulated by the Food and Drug Administration, and there is no set meaning across manufacturers. That’s why it’s important to check dosages, comparing them across different products if necessary.

In a statement, BI pointed out that by recommending that they remove those words from the package, the NAD is banning a commonly used phrase in the over-the-counter drug industry. “NAD’s decision effectively prohibits the use of this term to specify even inter-brand differences in strengths that have been used in a variety of OTC products for many years,” they complained. Will this mean an end to such labels in the future?

NAD Recommends Boehringer Ingelheim Discontinue ‘Maximum Strength’ Claim for DulcoGas Product [NAD]

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