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OTC Products

Terms in this set (17)

What is required to be on an OTC label?
keep out of reach of children, for external use only, if pregnant or breast feeding consult a healthcare professional first
What is recommended but not required to be on an OTC product?
NDC
What are the established thresholds for calcium, magnesium, potassium, and sodium containing OTC products and what does this mean?
calcium>20, magnesium>8, potassium>5, sodium>5 and if the amount is greater than this threshold they must state how much is in the product
Above what level of calcium is it required to have the statement "ask your doctor before taking if you have kidney stones or a calcium restricted diet"?
3200mg
Above what level of magnesium is it required to have the statement "ask your doctor before taking if you have kidney disease or a magnesium restricted diet"?
600mg
Above what level of potassium is it required to have the statement "ask your doctor before taking if you have kidney stones or a potassium restricted diet"?
>975mg
What level of Na is an OTC product allowed to have to be considered sodium free?
<5mg
What level of Na is an OTC product allowed to have to be considered very low sodium?
<35mg
What level of Na is an OTC product allowed to have to be considered low sodium?
<140mg
What level of Na is an OTC product that requires a patient to ask their doctor before using if they are on a sodium restricted diet?
>140mg
What are the storage requirements for pseudoephedrine?
it must be stored behind any counter or in a locked safe
What is the base amount of pseudoephedrine per 30mg tablet?
24.6mg
What is the max amount of pseudoephedrine sold per day?
3.6g
What is the max amount of pseudoephedrine sold per 30 days?
9g
What is the max amount of pseudoephedrine sold in a 30 day period from mail order purchase?
7.5g
What is required to be on the drug facts panel of an OTC prescription?
uses, active ingredient, warnings, contact information
When do you not have to log a pseudoephedrine sale?
if the patient purchases 1-2 30mg tablets
Sets found in the same folder