Labeling Requirements for Over-the-Counter Drugs is which subpart?
C
Specific Labeling Requirements for Specific Drug Products is which subpart?
G
Other Exemptions is which subpart?
E
Exemptions from Adequate Directions for Use is which subpart?
D
Labeling Requirements for Prescription Drugs and/or Insulin is which subpart?
B
Labeling Claims for Drugs in Drug Efficacy Study is which subpart?
F
General Labeling Provisions is which subpart?
A
What refers to:
Information printed on the label and outside package of the
drug product; includes the package insert Information
printed by the pharmacist on the prescription label for a drug that
is being dispensed
Labeling
Adequate directions for use must be displayed for which drugs?
OTC
Display of written, printed or graphic matter appearing on the
immediate commercial container of the drug product and placed there by
the manufacturer refers to what?
Label
Durham-Humphrey Amendment of 1951 states that drugs do NOT have to
have adequate directions for use IF they are intended for dispensing
by pharmacists provided WHAT is printed on the container label?
Rx only
Over-the-counter, non-prescription drug products must have what requirements?
Safe for use without medical supervision Suitable for
self-diagnosis Adequate directions for use
Labels must have �Drug Facts� section on its labeling containing:
Active ingredient(s) Use Warnings
Inactive ingredients Purpose Directions
Other information
Labels also contain:
Lot number, Expiration date, Net quantity of contents
Name and Address of manufacturer, packer or distributor
What to do if an overdose occurs
Labels for OTC drug products intended for oral administration must
indicate the amount of sodium present if the amount is ? what quantity
per dosage unit for SODIUM?
5 mg
True or False: The SODIUM content refers to NaCl
False; sodium only. Not NaCl
What is the electrolyte threshold for Calcium?
20 mg
What quantity of Calcium requires the warning statement?
3.2 g
What quantity of Magnesium contains the warning statement?
600 mg
What is the electrolyte threshold for Potassium?
5 mg
If the maximum daily dose of the drug product contains ? what
quantity of Na, then the label must contain the warning:
�Ask a doctor before use if you have a sodium-restricted diet�
140 mg
What is the electrolyte threshold for Magnesium?
8 mg
What quantity of Potassium contains the warning statement
975 mg
Contains 35 mg or less of sodium (Na) in the labeled maximum dose
refers to what?
Very low sodium
Contains 5 mg or less of sodium (Na) in the labeled maximum dose
refers to what?
Sodium free
Contains 140 mg of less of sodium (Na) in the labeled maximum dose
refers to what?
Low sodium
Active ingredient for oral ingestion includes what types of sodium?
Sodium bicarbonate sodium phosphate sodium
biphosphate
Rectal administration of sodium corresponds to what active ingredients?
dibasic sodium phosphate monobasic sodium
phosphate (sodium content greater than/equal to 5 mg)
FD&C Yellow No. 5 (tartrazine) and Sulfites must contain what warning?
May precipitate allergies
Mineral Oil must contain which label warning?
Use at bedtime only; avoid use in infants and pregnancy
Aspartame (phenylalanine) must contain which label warning?
Notice of phenylketonurics
Products containing > 5%, it is dangerous (potentially fatal) if
used other than as directed; keep out of reach of children refers to
which products label warning?
Wintergreen oil
Sodium phosphate contains which label warning?
may not exceed 90 mL per OTC container
Do not exceed prescribed dose; contact MD if breathing
difficulty persists" refers to which products label warning?
Isoproterenol inhalation
Possible kidney damage when taken in large amount or for a long
period of time" refers to which product's label warning?
Acetophenetidine (phenacetin)
Salicylates (including aspirin) must contain which label warning?
Reye's syndrome
Temporary relief; Max 2 day use; Consult MD if persistent
pain" corresponds to which product's label warning?
OTCs for Minor Sore Throat
Consult physician before taking if patient consumes ? 3
alcoholic beverages per day" refers to which warning?
Alcohol warning
Alcohol warnings are required for which products?
Required for internal analgesic and antipyretics
Acetaminophen, aspirin, ibuprofen, naproxen, ketoprofen,
etc.
Obesity agents � Risk of serious, life-threatening toxicities
correspond to which drug's label warning
Drugs with Thyroid Hormone Activity/Digitalis
Choking hazard if not taken with adequate amount of water (at
least 8 oz or 240 mL)" corresponds to which drug type's label warning?
Water-soluble Gums Hydrophilic Gums
Hydrophilic Mucilloids
No protection against HIV" should be provided on which
drug's label warning?
OTC Vaginal Contraceptives/Spermicides
Effectiveness Claim � SPF and water resistance statement"
must be on what product types label warning?
OTC Sunscreen Drug Products
Boxed statement in RED: �For emergency use to cause vomiting in
poisoning. Before using, call physician, the poison prevention center,
or hospital emergency room immediately for advice.� correlates to
which product's label warning?
Ipecac syrup
Ipecac syrup can only be sold in what size containers?
30 mL (1 ounce)
What is the usual dose of Ipecac syrup for a patient that is greater
than 1 year old?
15 mL
Which label's warning corresponds to:
Keep out of reach of children Do not use in conscious
persons involving corrosives, petroleum distillates such as
kerosene, gasoline, cleaning fluids, or for strychnine
poisoning
Ipecac syrup
Coloring agents may be present in oral and topical dosage forms but
prohibited from what?
Ophthalmic Parenterals
WHAT may be present in parenterals for stability but not listed on
the label?
Inert gases
What may be listed by common names due to complexity of ingredients
Fragrances and flavors
What are listed alphabetically but separate from active ingredients?
Additives
It is considered what to list inactive adjuvants?
GMP
Labels for OTC drug products intended for systemic use require the
general warning:
�As with any drug, if you are pregnant or nursing a baby, seek the
advice of a health professional before using this product�
Exceptions to the labeling requirements include drug products that
are intended:
To benefit the fetus or nursing infant Exclusively for
pediatric use
Aspirin containing products must have the warning:
�It is especially important not to use this product during the last
three months of pregnancy unless specifically directed to do so by a doctor�