WASHINGTON MPJE EXAM 2024 WITH GUARANTEED ACCURATE ANSWERS |VERIFIED |UPDATED
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Course
WASHINGTON MPJE
Institution
WASHINGTON MPJE
If any required OTC labeling information is missing, the drug is considered - ACCURATE ANSWERmisbranded
Requirements for an OTC drug label - ACCURATE ANSWER1) Principal Display Panel
2) Statement of Identity - drug name + pharmacological category/intended action (*should be on principal display...
WASHINGTON MPJE EXAM 2024
WASHINGTON MPJE EXAM 2024 WITH GUARANTEED ACCURATE ANSWERS |
VERIFIED |UPDATED
Labeling on prescription drugs is written for... - ACCURATE
ANSWER✅✅healthcare providers
Labeling on OTC drugs is written for... - ACCURATE ANSWER✅✅patients
If any required OTC labeling information is missing, the drug is considered -
ACCURATE ANSWER✅✅misbranded
Requirements for an OTC drug label - ACCURATE 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
This should be on the Principal Display Panel of an OTC drug - ACCURATE
ANSWER✅✅Statement of Identity = drug name + pharmacologic
category/intended action
Is the "Drug Facts" Panel on OTCs FDA approved? - ACCURATE
ANSWER✅✅Yes
In an NDC require on the OTC labeling? - ACCURATE
ANSWER✅✅Requested but *not required*
Adequate directions for self use include: - ACCURATE ANSWER✅✅- dosing
- preparation
- frequency
- duration
- time
- route
Required elements of "Drug Facts" Panel - ACCURATE 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? -
ACCURATE ANSWER✅✅- electrolyte information ( Na, Ca, Mg, K)
- inactive ingredients
- other info required by monograph, regulations or labeling
Unique OTC drug warnings to remember - ACCURATE 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 -
ACCURATE 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? - ACCURATE
ANSWER✅✅Aspirin-containing products
"Ask a doctor before use if you have... " is for ________ - ACCURATE
ANSWER✅✅Conditions
, "Ask a doctor or pharmacist before use if you have..." is for _______ -
ACCURATE ANSWER✅✅Drug-drug and drug-food interactions
"When using this product..." is for_______ - ACCURATE ANSWER✅✅Side
effects and substances to avoid
"Stop and ask a doctor if..." is for_______ - ACCURATE ANSWER✅✅signs of
toxicity
"Do not use..." is for ______ - ACCURATE 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? - ACCURATE 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
Must also list amount of electrolyte *per dose*
Which electrolytes require kidney *stone* warning? - ACCURATE
ANSWER✅✅K, Mg, Ca (all but Na)
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