openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Heat prostration can occur with belladonna alkaloids in high temperatures. Diarrhea may be an early symptom of incomplete intestinal obstruction, particularly in patients with ileostomy or colostomy. In this instance, treatment with this drug could be harmful. PHENOHYTRO ® ELIXIR may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. Phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be necessary for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence. Barbiturates should be used with caution in patients with hepatic dysfunction.
ADVERSE REACTIONS Call your doctor for medical advice about side effects. Adverse reactions associated with anticholinergics and/or anticonvulsants are: dry mouth; tachycardia; urinary hesitancy and retention; palpitation; blurred vision; prolonged pupil dilation; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, hives and/or other dermal manifestations; decreased sweating; impotence; suppression of lactation; constipation; bloated feeling and musculoskeletal pain. Elderly patients may react with symptoms of excitement, agitation and drowsiness to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.