Important Safety Information

Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials,
ORACEA Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established

You are encouraged to report negative side effects of prescription drugs to the FDA
Visit www.fda.gov/medwatch
or call 1-800-FDA-1088

*30 mg immediate release and 10 mg delayed release beads

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Important Safety Information

Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, ORACEA Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

*30 mg immediate release and 10 mg delayed release beads