WASHINGTON MPJE EXAM
ACTUAL COMPLETE QUESTIONS
100 PERCENT CORRECT
◉ Labeling on OTC drugs is written for... Answer: patients
◉ If any required OTC labeling information is missing, the drug is
considered Answer: misbranded
◉ Requirements for an OTC drug label Answer: 1) Principal Display
Panel
2) Statement of Identity - drug name + pharmacological
category/intended action (*should be on principal display panel*)
3) Net quantity of contents (weight, measure or numerical count)
4) Name AND address of manufacturer/packager/distributor
5) Adequate directions for self-use
6) "Drug Facts" Panel
◉ This should be on the Principal Display Panel of an OTC drug
Answer: Statement of Identity = drug name + pharmacologic
category/intended action
,◉ Is the "Drug Facts" Panel on OTCs FDA approved? Answer: Yes
◉ In an NDC require on the OTC labeling? Answer: Requested but
*not required*
◉ Adequate directions for self use include: Answer: - dosing
- preparation
- frequency
- duration
- time
- route
◉ Required elements of "Drug Facts" Panel Answer: 1) Active
Ingredient (including quantity per dose)
2) Purpose (pharmacologic category/intended use)
3) Uses (indications)
4) Warnings
5) Directions (for specific age groups/populations)
6) Other information (Electrolyte labeling, inactive ingredients)
7) Contact information ("Questions" + phone #)
,◉ What is included in the "other information" section of a "Drug
Facts" panel? Answer: - electrolyte information ( Na, Ca, Mg, K)
- inactive ingredients
- other info required by monograph, regulations or labeling
◉ Unique OTC drug warnings to remember Answer: - sore throat
- allergic reaction and asthma alert
- flammability
- Reye's syndrome
- Choking
- Dosage for Sodium Phos
- STD
- "Keep out of reach of children" + accidental ingestion/overdose
◉ Which OTC drugs are exempt from "If pregnant or
breastfeeding...." warning Answer: - If drug is intended to benefit the
fetus or nursing infant
- If labeled exclusively for pediatric use
◉ What OTC drugs require a special additional pregnancy warning?
Answer: Aspirin-containing products
, ◉ "Ask a doctor before use if you have... " is for ________ Answer:
Conditions
◉ "Ask a doctor or pharmacist before use if you have..." is for _______
Answer: Drug-drug and drug-food interactions
◉ "When using this product..." is for_______ Answer: Side effects and
substances to avoid
◉ "Stop and ask a doctor if..." is for_______ Answer: signs of toxicity
◉ "Do not use..." is for ______ Answer: Contraindications
◉ Which electrolytes have to be labeled with a warning if they
exceed a certain threshold in an OTC product?
What is the warning? Answer: Na
K
Mg
Ca
Ask a doctor before use if you have kidney stones/kidney disease or
a Na/K/Mg/Ca restricted diet
ACTUAL COMPLETE QUESTIONS
100 PERCENT CORRECT
◉ Labeling on OTC drugs is written for... Answer: patients
◉ If any required OTC labeling information is missing, the drug is
considered Answer: misbranded
◉ Requirements for an OTC drug label Answer: 1) Principal Display
Panel
2) Statement of Identity - drug name + pharmacological
category/intended action (*should be on principal display panel*)
3) Net quantity of contents (weight, measure or numerical count)
4) Name AND address of manufacturer/packager/distributor
5) Adequate directions for self-use
6) "Drug Facts" Panel
◉ This should be on the Principal Display Panel of an OTC drug
Answer: Statement of Identity = drug name + pharmacologic
category/intended action
,◉ Is the "Drug Facts" Panel on OTCs FDA approved? Answer: Yes
◉ In an NDC require on the OTC labeling? Answer: Requested but
*not required*
◉ Adequate directions for self use include: Answer: - dosing
- preparation
- frequency
- duration
- time
- route
◉ Required elements of "Drug Facts" Panel Answer: 1) Active
Ingredient (including quantity per dose)
2) Purpose (pharmacologic category/intended use)
3) Uses (indications)
4) Warnings
5) Directions (for specific age groups/populations)
6) Other information (Electrolyte labeling, inactive ingredients)
7) Contact information ("Questions" + phone #)
,◉ What is included in the "other information" section of a "Drug
Facts" panel? Answer: - electrolyte information ( Na, Ca, Mg, K)
- inactive ingredients
- other info required by monograph, regulations or labeling
◉ Unique OTC drug warnings to remember Answer: - sore throat
- allergic reaction and asthma alert
- flammability
- Reye's syndrome
- Choking
- Dosage for Sodium Phos
- STD
- "Keep out of reach of children" + accidental ingestion/overdose
◉ Which OTC drugs are exempt from "If pregnant or
breastfeeding...." warning Answer: - If drug is intended to benefit the
fetus or nursing infant
- If labeled exclusively for pediatric use
◉ What OTC drugs require a special additional pregnancy warning?
Answer: Aspirin-containing products
, ◉ "Ask a doctor before use if you have... " is for ________ Answer:
Conditions
◉ "Ask a doctor or pharmacist before use if you have..." is for _______
Answer: Drug-drug and drug-food interactions
◉ "When using this product..." is for_______ Answer: Side effects and
substances to avoid
◉ "Stop and ask a doctor if..." is for_______ Answer: signs of toxicity
◉ "Do not use..." is for ______ Answer: Contraindications
◉ Which electrolytes have to be labeled with a warning if they
exceed a certain threshold in an OTC product?
What is the warning? Answer: Na
K
Mg
Ca
Ask a doctor before use if you have kidney stones/kidney disease or
a Na/K/Mg/Ca restricted diet
