Drug information for APHTHASOL

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
PASTE; DENTAL	5%	Prescription	(Reference Drug)	AMLEXANOX	amlexanox	ULURU	20511 2002-06-11 Letter 2002-06-11 Label 1997-11-20 Review

Drug Adverse Effects information for APHTHASOL

Role code	Indications	Reaction	# Reports
C	CONTRACEPTION	ABDOMINAL PAIN	2
C	CONTRACEPTION	CHOLECYSTITIS ACUTE	2
C	CONTRACEPTION	GALLBLADDER DISORDER	2
C	CONTRACEPTION	GASTROINTESTINAL DISORDER	2
C	CONTRACEPTION	KIDNEY INFECTION	2
C	CONTRACEPTION	PAIN	2
C	CONTRACEPTION	PREGNANCY ON ORAL CONTRACEPTIVE	2
C	CONTRACEPTION	STRESS	2
C	CONTRACEPTION	URINARY TRACT INFECTION	2
C	CONTRACEPTION	VOMITING	2
C	CONTRACEPTION	WEIGHT DECREASED	2
C	CONTRACEPTION	WEIGHT GAIN POOR	2
C	POLYCYSTIC OVARIES	ABDOMINAL PAIN	1
C	POLYCYSTIC OVARIES	CHOLECYSTITIS ACUTE	1
C	POLYCYSTIC OVARIES	GALLBLADDER DISORDER	1
C	POLYCYSTIC OVARIES	GASTROINTESTINAL DISORDER	1
C	POLYCYSTIC OVARIES	KIDNEY INFECTION	1
C	POLYCYSTIC OVARIES	PAIN	1
C	POLYCYSTIC OVARIES	PREGNANCY ON ORAL CONTRACEPTIVE	1
C	POLYCYSTIC OVARIES	STRESS	1
C	POLYCYSTIC OVARIES	URINARY TRACT INFECTION	1
C	POLYCYSTIC OVARIES	VOMITING	1
C	POLYCYSTIC OVARIES	WEIGHT DECREASED	1
C	POLYCYSTIC OVARIES	WEIGHT GAIN POOR	1

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