Section F - Requirements for Marketed Drug Products Flashcards
USAN
United States Adopted Names Council
-responsible for designating generic names for drugs
OPDP
Office of Prescription Drug Promotion
-division of FDA in charge of monitoring for bad or misleading prescription drug advertisements-
FD&C Yellow No. 5 (tartrazine) labeling
presence must be disclosed and “precautions” must list for possible allergies
Aspartame labeling
warning: Phenylketonurics: Contains phenylalanine __mg per __(dosage unit)
Sulfites labeling
must have allergy warning in labeling
Mineral Oil labeling
- only to be used HS
- should not be used in infants unless advised by physician
- discourage use in pregnancy
Wintergreen oil (methyl salicylate) labeling
if contains >5% should indicate that using other than directed is dangerous and to keep out of reach of children
Sodium Phosphate labeling
OTC container cannot be >90mL per
Isoproterenol Inhalation Products labeling
- don’t exceed prescribed dose
- contact physician if breathing difficulty persists
Ipecac Syrup labeling
- must say “For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice”
- must say “Warning: Keep out of reach of children. Do not use in unconscious persons or for poisoning involving corrosives (lyle, strong acids), petroleum distillates such as kerosene, gasoline, cleaning fluids, or strychnine”
- dose is one tablespoon full for patients >1yo
- may only be sold in 1 oz. containers
Acetophenetidin (Phenacetin) labeling
possible kidney damage when taken over long periods of time
Salicylates (including aspirin) labeling
must have warning regarding Reye’s Syndrome
Alcohol Warning
must be on APAP and NSAIDs to warn consumers before taking if they consume >3 alcoholic beverages per day
