openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
Warnings If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not give to children under 12 years of age. For external use only. Avoid contact with the eyes; in the event of contact, flush with water and seek advice from medical personnel. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. Some individuals may be sensitive to tea tree or other oils. If you are pregnant or breast-feeding, ask a health professional before use. Not to be used with children under 2 years of age. Keep all medicines out of the reach of children.