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.
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.
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.
The dosage of RE-PB Hyos Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours.
Starting Dosage
Body Weight
q4h
q6h
10 lb. (4.5 kg)
0.5 mL
0.75 mL
20 lb. (9.1 kg)
1.0 mL
1.5 mL
30 lb. (13.6 kg)
1.5 mL
2.0 mL
50 lb. (22.7 kg)
1/2 tsp
3/4 tsp
75 lb. (34 kg)
3/4 tsp
1 tsp
100 lb. (45.4kg)
1 tsp
1 1/2 tsp
The dosage of RE-PB Hyos Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours.
Starting Dosage
Body Weight
q4h
q6h
10 lb. (4.5 kg)
0.5 mL
0.75 mL
20 lb. (9.1 kg)
1.0 mL
1.5 mL
30 lb. (13.6 kg)
1.5 mL
2.0 mL
50 lb. (22.7 kg)
1/2 tsp
3/4 tsp
75 lb. (34 kg)
3/4 tsp
1 tsp
100 lb. (45.4kg)
1 tsp
1 1/2 tsp