OTC-drugs

Take the drug exacdy as prescribed by the primary health care provider. Do not increase or decrease die dosage, and do not take any over-the-counter (OTC) drug without first consulting the primary health care provider. Notify the primary health care provider or dentist if the pain is not relieved. 

For an active ingredient in an OTC drug product that is exempt from bearing an expiration date under 211.137, the reserve sample shall be retained for 3 years after distribution of the last lot of the drug product containing the active ingredient. 

In the last four to five decades national health care expenditures for all types of health-related transactions, including dental, medical, hospital, prescription, and over-the-counter (OTC) drugs, has grown from about 5% of the country s gross domestic product (GDP) (national expenditures on all goods and services) to nearly 14% of the GDP today. Total health expenditures in the United States are now well over 1 trillion annually. 

NDMA statement on alcohol content of OTC drugs, Nonprescrip. Drug Manuf. Assoc. Newslett, Dec. 18 (1992). 

The FDA defines OTC drugs as safe and effective for use by the general public without a doctor s prescription. 

Over-the-cormter (OTC) drug review begins to ensure the safety, effectiveness, and appropriate labeling of drugs sold without prescription. Regulation of biologies (serums, vaccines, and blood products) is transferred from NIH to FDA. 

Many drugs are simply discontinued for reasons that may not have to do with safety. The OTC drugs and drug products used as a compoxmd in other drugs may also be withdrawn. 

Prescription Drugs OTC Drugs Vitamins and Minerals Other Nutritional Supplements Herbal Products OTC Homeopathic Products... 

The marketplace would be safer if the FDA could regulate the upper dosage limits of vitamins and minerals and could hold other nutritional supplements to at least the same standards as those for OTC drugs. But DSHEA prevents the FDA from doing this unless a product poses an imminent hazard. 

Ironically, by the time DSHEA was enacted, the OTC drug review had rid the marketplace of nearly all fhe sfandard OTC products that had been marketed with unsubstantiated claims. In contrast, few diefary supplements promoted with disease-related claims can live up to such claims. A few years ago, a review of 964 herbs and diefary supplemenf products listed in the Natural Medicines Comprehensive Database found fhaf only 15% had been proven safe and only 11% had been proven effective for the indications for which fhey were advocafed. ... 

---