If you are:
FDB Only When Necessary: AVAILABLE DATA SUGGEST NO KNOWN RISK; OTC PRODUCT, NO FDA PREGNANCY WARNINGS
Only When Necessary: INSUFFICIENT HUMAN & ANIMAL DATA. FDA CATEGORY C IN MULTI-INGREDIENT PRODUCTS
Precaution: INSUFFICIENT DATA AVAIL. MAY POSSIBLY CAUSE SEDATION/ANTIMUSCARINIC EFFECTS.
No Known Risk: LOW LEVELS EXCRETED WITH LOW RISK FOR ADVERSE EFFECTS IN INFANT
An adult over 60:
management or monitoring precaution: Neuro/Psych-Anticholinergic effects may cause sedation, worsen cognitive impairment and increase fall risk. Non-sedating agents preferred. Gastrointestinal-May cause or worsen pre-existing constipation. Genitourinary-Best avoided in patients with urinary retention from any cause.
management or monitoring precaution: Hepatic-Elderly are more susceptible to hepatotoxicity. Strict adherence to a maximum daily dose of 3000mg is advised.
Giving Aceta-Gesic (with phenyltolox) tablet to a child under 12:
management or monitoring precaution: Use weight based dosing in children less than 12 years.
Contraindication: Possible CNS excitation and seizure risk in newborns.