OVERDOSAGE SECTION.

OVERDOSAGE. 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. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be used.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 4 OZ GRAPE. NDC 50742-666-04 Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir Grape FlavoredEach mL (1 teaspoonful) contains: Phenobarbital, USP........................ 16.2 mg Hyoscyamine Sulfate, USP........... 0.1037 mg Atropine Sulfate, USP................... 0.0194 mg Scopolamine Hydrobromide, USP....0.0065 mgAlcohol not more than 23.8%DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSINGRx Only4 FL OZIngenus. bottle-label-4oz-grape.

ABUSE SECTION.

Abuse. Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with history of physical and/or psychological dependence upon drugs (see WARNINGS).

ADVERSE REACTIONS SECTION.

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 few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. Phenobarbital may produce exctextent in some patients, rather than sedative effect. To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term studies in animals have not been performed to evaluate carcinogenic potential.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. This drug combination provides natural belladonna alkaloids in specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.INDICATIONS AND USAGE Based on 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 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. Final classification of the less-than-effective indications requires further investigation. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

CONTRAINDICATIONS SECTION.

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 exctextent.. 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.

DEPENDENCE SECTION.

Dependence. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

DESCRIPTION SECTION.

DESCRIPTION. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir Grape Each 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 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.

DOSAGE & ADMINISTRATION SECTION.

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 minimum of adverse effects. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir. Adults: One or two teaspoonfuls of elixir three or four times day according to conditions and severity of symptoms.Pediatric patients: may be dosed every to hours. Use pediatric dosing device or oral syringe to measure the dose. Starting Dosage Body weight Every hours Every hours10 lb. (4.5 kg) 0.5 mL 0.75 mL 20 lb. (9.1 kg) mL 1.5 mL 30 lb. (13.6 kg) 1.5 mL mL 50 lb. (22.7 kg) 2.5 mL 3.75 mL 75 lb. (34 kg) 3.75 mL mL 100 lb. (45.4 kg) mL 7.5 mL.

DRUG ABUSE AND DEPENDENCE SECTION.

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

DRUG INTERACTIONS SECTION.

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.

GENERAL PRECAUTIONS SECTION.

General. Use with caution in patients with:autonomic neuropathyhepatic or renal diseasehyperthyroidismcoronary heart diseasecongestive heart failurecardiac arrhythmiastachycardiahypertensionBelladonna alkaloids may produce delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, curare-like action may occur.Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir Mint contains FD&C Yellow No. (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.. autonomic neuropathy. hepatic or renal disease. hyperthyroidism. coronary heart disease. congestive heart failure. cardiac arrhythmias. tachycardia. hypertension.

GERIATRIC USE SECTION.

Geriatric Use. Elderly patients may react with symptoms of exctextent, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir Grape is purple colored, grape flavored liquid.4 fl oz (118 mL) bottles- NDC 50742-666-04.1 Pint (473 mL) bottles- NDC 50742-666-16.Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir Mint is green colored, mint flavored liquid.4 fl oz (118 mL) bottles- NDC 50742-665-04.1 Pint (473 mL) bottles- NDC 50742-665-16.Avoid FreezingStore Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir at 20 25C (68 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.Dispense in tight, light-resistant container as defined in the USP using child-resistant closure.DEA EXEMPT PRODUCTManufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408Revised: 05/2021 LF-122298-01 MPL-100. fl oz (118 mL) bottles- NDC 50742-666-04.. Pint (473 mL) bottles- NDC 50742-666-16.. fl oz (118 mL) bottles- NDC 50742-665-04.. Pint (473 mL) bottles- NDC 50742-665-16.. logo.

INFORMATION FOR PATIENTS SECTION.

Information for Patients. 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 motor vehicle or other machinery, and not to perform hazardous work.

NURSING MOTHERS SECTION.

Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir is administered to nursing woman.

PRECAUTIONS SECTION.

PRECAUTIONS. General. Use with caution in patients with:autonomic neuropathyhepatic or renal diseasehyperthyroidismcoronary heart diseasecongestive heart failurecardiac arrhythmiastachycardiahypertensionBelladonna alkaloids may produce delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, curare-like action may occur.Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir Mint contains FD&C Yellow No. (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.. autonomic neuropathy. hepatic or renal disease. hyperthyroidism. coronary heart disease. congestive heart failure. cardiac arrhythmias. tachycardia. hypertension. Information for Patients. 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 motor vehicle or other machinery, and not to perform hazardous work.. 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.. Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term studies in animals have not been performed to evaluate carcinogenic potential.. Pregnancy. Animal reproduction studies have not been conducted with Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (see WARNINGS).. Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir is administered to nursing woman.. Geriatric Use. Elderly patients may react with symptoms of exctextent, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.

PREGNANCY SECTION.

Pregnancy. Animal reproduction studies have not been conducted with Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (see WARNINGS).

WARNINGS SECTION.

WARNINGS. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir can cause fetal harm when administered to 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 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 motor vehicle or other machinery, and not to perform hazardous work.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. Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with history of physical and/or psychological dependence upon drugs.Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.