Must disclose presence and provide warning in "precautions" section of label that may cause allergic reaction in certain susceptible persons.

Must contain warning in "precautions" section of labeling to the following effect: Phenylketonurics: Contains Phenylalanine __ mg

Prescription drugs containing sulfite must contain a allergy warning in the warnings section of labeling

Requires warning to be taken only at bedtime and not to be used in infants unless under advise of physician. Label can also not encourage use during pregnancy.

Any drug containing more than 5% methyl salicylate must include warning that any use other than directed may be dangerous and that the article should be kept out of reach from children.

Limits the amount to no more than 90 mL per OTC container.

Isoproterenol (Inhalation)

Include warning do.not exceed dose prescribed and to contact physician if breathing difficulty persists.

Potassium Salt Preparations

Requires warnings about the nonspecific small bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric coated thiazides with potassium salts

"For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice. Warning: Keep out of reach of children and do not use in unconscious person

Dosage: 1 tablespoon or 15 mL in those age > 1 years old May be sold in 30 mL containers

Phenacetin (Acetophenetidin)

Must contain warning about possible kidney damage when taken in large amounts for a long period of time

Warning: Reyes Syndrome in Children If 1 and 1/4 grains (Pediatrics) may not be sold in more than 36 tablet containers.

Internal analgesics and antipyretics must include in label no more than 3 drinks per day and consult doctor prior

STD Alert: This product does not protect against HIV/AIDS or other STDs and may increase risk of getting HIV from an infected partner

OTC Products for Minor Sore Throat

"For the temporary relief of minor sore throat" Do not use for more than 2 days or administer to children less than 3 years unless directed

Exceptions to the tamper evident packaging

Dermatologicals, Dentifrices, Lozenges, Insulins

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FDCA

Special Warning Requirements

Question	Answer
Tartrazine	Must disclose presence and provide warning in "precautions" section of label that may cause allergic reaction in certain susceptible persons.
Aspartame	Must contain warning in "precautions" section of labeling to the following effect: Phenylketonurics: Contains Phenylalanine __ mg
Sulfites	Prescription drugs containing sulfite must contain a allergy warning in the warnings section of labeling
Mineral Oil	Requires warning to be taken only at bedtime and not to be used in infants unless under advise of physician. Label can also not encourage use during pregnancy.
Wintergreen Oil	Any drug containing more than 5% methyl salicylate must include warning that any use other than directed may be dangerous and that the article should be kept out of reach from children.
Sodium Phosphate	Limits the amount to no more than 90 mL per OTC container.
Isoproterenol (Inhalation)	Include warning do.not exceed dose prescribed and to contact physician if breathing difficulty persists.
Potassium Salt Preparations	Requires warnings about the nonspecific small bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric coated thiazides with potassium salts
Ipecac Syrup	"For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice. Warning: Keep out of reach of children and do not use in unconscious person
Ipecac Syrup	Dosage: 1 tablespoon or 15 mL in those age > 1 years old May be sold in 30 mL containers
Phenacetin (Acetophenetidin)	Must contain warning about possible kidney damage when taken in large amounts for a long period of time
Salicylates	Warning: Reyes Syndrome in Children If 1 and 1/4 grains (Pediatrics) may not be sold in more than 36 tablet containers.
Alcohol Warning	Internal analgesics and antipyretics must include in label no more than 3 drinks per day and consult doctor prior
Nonoxynol 9	STD Alert: This product does not protect against HIV/AIDS or other STDs and may increase risk of getting HIV from an infected partner
OTC Products for Minor Sore Throat	"For the temporary relief of minor sore throat" Do not use for more than 2 days or administer to children less than 3 years unless directed
Exceptions to the tamper evident packaging	Dermatologicals, Dentifrices, Lozenges, Insulins

Created by: lvilla26

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