Heat prostration can occur with belladonna alkaloids in high temperatures.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.
In this instance, treatment with this drug could be harmful.
RE-PB Hyos 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 needed 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.
There is currently no manufacturer warning information available for this drug.
FDA has classified the following indications as “possibly” effective: For use as adjunctive therapy in the treatment of
irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as
adjunctive therapy in the treatment of duodenal ulcer.
IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ ANTISPASMODIC DRUGS AID IN THE
HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
Each 5 mL (teaspoonful) of elixir contains:
Phenobarbital, USP ……………………………………… 16.2 mg
(WARNING: may be habit forming)
Hyoscyamine Sulfate, USP ………………………… 0.1037 mg
Atropine Sulfate, USP ………………………………. 0.0194 mg
Scopolamine Hydrobromide, USP ………………. 0.0065 mg
Alcohol not more than 23.8%
INACTIVE INGREDIENTS:
Artificial Grape Flavor, Ethyl Alcohol, FD and C Blue #1, FD and C Red #40, Glycerin, Purified Water USP, Sodium Saccharin,
Sorbitol Solution 70%, and Sucrose.
