Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide .0194 mg/5mL
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide · ELIXIR · Ingenus Pharmaceuticals, LLC
This is a prescription oral elixir containing a barbiturate (phenobarbital) combined with anticholinergic medications, historically used to treat gastrointestinal conditions and reduce cramping and spasms. The medication works by calming stomach and intestinal muscle contractions while also providing mild sedative effects.
Key Facts
- Brand Name
- Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
- Generic Name
- Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
- NDC Code (Product)
50742-665- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Strength
- .0194 mg/5mL
- Dosage Form
- ELIXIR
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Marketing Start
- 08/01/2021
Recall History
Rx PAK
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Full Prescribing Information
Dosage & Administration
DOSAGE AND ADMINISTRATION The dosage of Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir. 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. Use a pediatric dosing device or oral syringe to measure the dose. Starting Dosage Body weight Every 4 hours Every 6 hours 10 lb. (4.5 kg) 0.5 mL 0.75 mL 20 lb. (9.1 kg) 1 mL 1.5 mL 30 lb. (13.6 kg) 1.5 mL 2 mL 50 lb. (22.7 kg) 2.5 mL 3.75 mL 75 lb. (34 kg) 3.75 mL 5 mL 100 lb. (45.4 kg) 5 mL 7.5 mL
Warnings
WARNINGS Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work. Phenobarbital may decrease the effect of ant…
Contraindications
CONTRAINDICATIONS glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis; in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.
Drug Interactions
Drug Interactions Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.
Adverse Reactions
ADVERSE REACTIONS Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations; and decreased sweating. Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the…
Frequently Asked Questions
What is Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide used for?
This is a prescription oral elixir containing a barbiturate (phenobarbital) combined with anticholinergic medications, historically used to treat gastrointestinal conditions and reduce cramping and spasms. The medication works by calming stomach and intestinal muscle contractions while also providing mild sedative effects.
Is Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide a controlled substance?
Yes, Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide?
The generic name for Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide is Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide. There are 5 other brand versions of Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide.
What is the NDC code for Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide .0194 mg/5mL?
The NDC (National Drug Code) for Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide .0194 mg/5mL is 50742-665, listed by Ingenus Pharmaceuticals, LLC.