Phenobarbital with Belladonna Alkaloids Elixir

Dosage form: elixir
Drug class:Anticholinergics / antispasmodics

Medically reviewed by Drugs.com. Last updated on Jul 1, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Phenobarbital with Belladonna Alkaloids Elixir

​Rx Only

Rev. 1/18​

DESCRIPTION:

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

Inactive ingredients:

Ethyl Alcohol, Purified Water, Glycerin, Methylparaben Sodium, Propylparaben Sodium, Saccharin Sodium, Xylitol, Citric Acid, Stevia Reb-A, Natural and Artificial Grape Flavor

CLINICAL PHARMACOLOGY:

This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.

INDICATIONS AND USAGE:

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.

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.

Phenobarbital with Belladonna Alkaloids Elixir i...