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Fexofenadine is used for relief from physical symptoms associated with seasonal allergic rhinitis and for treatment of hives, including chronic urticaria. [12] It does not cure, but rather prevents the aggravation of allergic rhinitis and chronic idiopathic urticaria, and reduces the severity of the symptoms associated with those conditions, providing relief from repeated sneezing, runny nose ...
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category".
Diphenhydramine is contraindicated in premature infants and neonates, as well as people who are breastfeeding. It is a pregnancy Category B drug. Diphenhydramine has additive effects with alcohol and other CNS depressants. Monoamine oxidase inhibitors prolong and intensify the anticholinergic effect of antihistamines. [50]
The U.S. Food and Drug Administration's (FDA) panel voted 12 to 1 against the late-stage data submitted by Merck for the drug gefapixant, which showed a small reduction in cough frequency compared ...
Benzonatate was first made available in the United States in 1958 as a prescription medication for the treatment of cough in individuals over the age of 10. [24] [25] There is a variety of prescription opioid-based cough relievers, such as hydrocodone and codeine, but have unwanted side effects and potential of abuse and diversion. [22]
The FDA's decision was not related to the drug's safety, Merck said, adding that it is reviewing the agency's feedback to determine next steps. US FDA declines to approve Merck's chronic cough ...
Common side effects include sleepiness, dry mouth, cough, vomiting, and diarrhea. [3] Use in pregnancy appears safe but has not been well studied and use when breastfeeding is of unclear safety. [5] It is classified as a second-generation antihistamine and works by blocking histamine H 1-receptors. [6] [3]
The Food and Drug Administration has reprimanded at least 28 companies this year, saying they failed to prove sufficient testing of ingredients used in over-the-counter drugs and consumer products ...