OTC product labels must contain the following items
Principal display panel
statement of identify
Drug facts panel
Directions for use
Net quantity
Expiration date
Expiration date must appear on what areas?
drug container and outer packaging if applicable
Is NDC required on packages?
FDA recommenda BUT not required for manufatures to include it
In other information section what are the 4 electrolytes need to ve included
calcium
magnesium
potassium
sodium
Each electrolyte has its own unique threshold
calcuim > ____
magnesium > _____
potassium > ______
sodium > ______
20 mg
8mg
5 mg
5 mg
calcuim threshold amount per daily dose is > ____ g
magnesium threshold amount per daily dose is > _____ mg
potassium > ---- mg
sodium >??
3.2 g
600 mg
975 mg
sodium free: < 5 mg
ver low sodium < 35 mg
low sodium < 14 mg
sodium restricted > 140 mg
Emergency contraception, there are two FDA approved tablets which are
levonorgestrel (available OTC)
ulipristal ( prescription only)
TThe OTC levonorgestrel products are FDA approved for up to ___ hours after unprotected intercourse.
Pharmacy can recommend them for up to ___ hours
72
120