FDA records indicate that there are no current recalls for this drug.
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Se-donna Pb Hyos Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
Se-Donna 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.
May be habit forming.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 AND IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATION.
History
There is currently no drug history available for this drug.
Other Information
Each 5 mL (one teaspoonful) for oral administration 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....................................................................23%
Sources
Se-donna Pb Hyos Manufacturers
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Seton Pharmaceuticals
Se-donna Pb Hyos | Seton Pharmaceuticals
The dosage of Se-Donna 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. (45.4 kg)
1 tsp
1 1/2 tsp
Children under 2 years of age: as directed by a physician.
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