OTC Products

Which type of products does not require physicians supervision and label must be written so the layperson can easily understand how to use it?

• OTC products

This is the approved FDA label use to educate patients

• drug facts panel

What must appear on the drug container and outer packaging?

• expiration date

Is the NDC required on OTC drug product packaging?

• No, it is recommended by the FDA but it does not require manufacturers to put it in the packaging

What are required information on the drug facts panel?

• active ingredients

• Purposes

• Uses

• Warnings

• Directions

• Other information

• Inactive ingredients

• Contact information

According to FDA how much calcium can be in OTC products?

• >20 mg

According to the FDA how much magnesium should be in an OTC product?

• >8 mg

According to the FDA how much potassium should be in OTC products?

• >5 mg

According to the FDA how much sodium should be in OTC products?

• >5mg

True/False: Label of OTC must include the amount of the electrolyte contained in the product

• True

What are the two FDA approved emergency contraceptives?

• levonorgestrel : is OTC

• Ulipristal: is in prescription known as Ella

Maximum amount of pseudoephedrine per day:

• 3.6 grams

Maximum pseudoephedrine per 30 days:

• 9 grams

Maximum pseudoephedrine in a 30 day from mail order pharmacy:

• 7.5 grams

How many mg of pseudoephedrine base does 30 mg tablets of pseudoephedrine hydrochloride contains?

• 24.6 grams

How long must logbook be kept in pharmacy when selling pseudoephedrine products?

• 2 years

What are the requirements to purchase pseudoephedrine products?

• show photo identification issued by state or government

• Verification of customers identity by store staff

• Documentation of product name and quantity sold

Above what magnesium intake should doctors be consulted?

• >600 mg

What should you do before using a product if you have a sodium restricted diet?

• Ask a doctor before using sodium

What is the threshold to ask your doctor be for use of sodium?

• > 140 mg

What is the threshold amount of calcium when you should ask the doctor before use if you have calcium restricted diet or kidney stones?

• >3.2 g

What is the threshold for potassium when you should ask your doctor before use if you have kidney disease or potassium restricted diet?

• >975 mg