Claritin's approval for OTC marketing was based on FDA's criteria for determining appropriate drugs for OTC use - namely that the drug in question treats a condition that consumers can diagnose and manage themselves; that the drug is sufficiently safe for use by consumers without direct prescriber supervision; and that the drug's label explains potential adverse effects and conditions of use with clear and understandable directions.
Antihistamines: Drugs that combat the histamine released during an allergic reaction by blocking the action of the histamine on the tissue. Antihistamines do not stop the formation of histamine nor do they stop the conflict between the IgE and antigen. Therefore, antihistamines do not stop the allergic reaction but protect tissues from some of its effects. Antihistamines frequently cause mouth dryness and sleepiness. Newer "non sedating" antihistamines are generally thought to be somewhat less effective. Antihistamine side effects that very occasionally occur include urine retention in males and fast heart rate.
Fetus: The unborn offspring from the end of the 8th week after conception (when the major structures have formed) until birth. Up until the eighth week, the developing offspring is called an embryo.
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