RE-PB Hyos Elixir

Each 5 mL (teaspoonful) of elixir contains:

Phenobarbital, USP ...................................      16.2 mg
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 & C Blue #1, FD & C Red #40, Glycerin, Purified Water USP,  Sodium Saccharin, Sorbitol Solution 70%, and Sucrose.

This drug combination provides peripheral anticholinergic/antispasmodic action and mild sedation.

RE-PB Hyos Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital produces restlessness and/or excitement.

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.

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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Call your doctor or local Poison Control Center if overdosage is suspected.