PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE elixir

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D), HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X), ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I), SCOPOLAMINE HYDROBROMIDE (UNII: 451IFR0GXB) (SCOPOLAMINE - UNII:DL48G20X8X)

Available from:

Ingenus Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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. Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs (see WARNINGS ). In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

Product summary:

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir - Grape is a purple colored, grape flavored liquid. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir - Mint is a green colored, mint flavored liquid. Avoid Freezing Store Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. DEA EXEMPT PRODUCT Manufactured for:  Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Revised: 05/2021  LF-122298-01 MPL-100

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE,
SCOPOLAMINE HYDROBROMIDE - PHENOBARBITAL, HYOSCYAMINE SULFATE,
ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE ELIXIR
INGENUS PHARMACEUTICALS, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE
HYDROBROMIDE ELIXIR
RX ONLY
REVISED: 05/21
DESCRIPTION
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE
HYDROBROMIDE ELIXIR - GRAPE
Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%)
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
Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin
Sodium, Artificial and
Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE
HYDROBROMIDE ELIXIR – MINT
Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%)
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
Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin
Sodium, Natural Mint
Flavor, FD&C Yellow #5, and FD&C Blue #1.
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
Based on a review of this drug by the National Academy of
Sciences-National Research
Council and/or other information, FDA has classified the indications
as follows: “Possibly”
effective: For use as adjunctive