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Reproductive toxicity studies of acetylcysteine solution in the rat given oral doses of acetylcysteine solution up to 1,000 mg/kg (5.2 times the human mucolytic dose) have also been reported in the literature.1 The only adverse effect observed was a slight non-dose-related reduction in fertility at dose levels of 500 or 1,000 mg/kg/day (2.6 or 5.2 times the human mucolytic dose) in the Segment I study

The results showed that over 72 weeks, patients on the 10 mg dose lost an average of about 12.8% of their body weight, and those on the 15 mg dose lost an average of 14.7% of their body weight

Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs, the notice said

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