Primary FDA-Approved Indications
Use primarily for nighttime allergy or cold symptoms in older children when non-sedating agents fail.
Seasonal/perennial allergic rhinitis with refractory nighttime symptoms
FDA ApprovedChildren ≥6 years (clinician-directed use ages 2–5)Level C
Transition to second-generation antihistamines once symptoms stabilize to minimize daytime cognitive effects.
Treatment Duration
Standard: Short bursts or bedtime dosing during flares
Evidence Sources
Children's Hospital Colorado Dose Table ()
Cold symptoms with troublesome nocturnal cough/sneezing
FDA ApprovedChildren ≥6 yearsLevel C
Adjunct to saline, humidifier, and rest. Not recommended for routine daytime use in school-age children due to sedation.
Treatment Duration
Standard: ≤5 nights
Evidence Sources
FDA Caution on Cold Products ()