If you are:
FDB Only When Necessary: AVAILABLE DATA SUGGEST NO KNOWN RISK; OTC PRODUCT, NO FDA PREGNANCY WARNINGS
Only When Necessary: CASE REPORT OF NEONATAL WITHDRAWAL SEIZURES WITH BUTALBITAL COMBO PRODUCT
Only When Necessary: REPORTS OF MISCARRIAGE,POOR FETAL GROWTH POSSIBLY ASSOC W/HIGH DOSES OF CAFFEINE
Precaution: HIGH DOSES MAY CAUSE HYPERACTIVITY AND WAKEFULNESS IN INFANT.
Precaution: POSSIBILITY OF CENTRAL NERVOUS SYSTEM DEPRESSION IN NURSING INFANT.
No Known Risk: LOW LEVELS EXCRETED WITH LOW RISK FOR ADVERSE EFFECTS IN INFANT
An adult over 60:
management or monitoring precaution: Neuro/Psych-Avoid in elderly with insomnia due to CNS stimulation effects.
management or monitoring precaution: General-Not recommended in the elderly due to sedation which may predispose to falls. May exacerbate depression. Renal-Renal excretion may increase adverse events with renal impairment. Monitor renal function.
management or monitoring precaution: Hepatic-Elderly are more susceptible to hepatotoxicity. Strict adherence to a maximum daily dose of 3000mg is advised.
Giving Orbivan capsule to a child under 12:
management or monitoring precaution: Use weight based dosing in children less than 12 years.
management or monitoring precaution: Adverse CNS effects of insomnia, restlessness, nervousness, and mild delirium, more severe in children.
Severe Precaution: Safety and effectiveness not established age < 12 years.
management or monitoring precaution: Caution in: seizure disorder, cardiovascular disease, or in premature neonates with renal or hepatic impairment.