Label: PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE elixir

  • NDC Code(s): 50742-665-04, 50742-665-16, 50742-666-04, 50742-666-16
  • Packager: Ingenus Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated August 1, 2021

If you are a consumer or patient please visit this version.

  • 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 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 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; 
    • 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.

  • 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 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 a 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.

  • PRECAUTIONS

    General

    Use with caution in patients with:

    • autonomic neuropathy
    • hepatic or renal disease
    • hyperthyroidism
    • coronary heart disease
    • congestive heart failure
    • cardiac arrhythmias
    • tachycardia
    • hypertension

    Belladonna alkaloids may produce a 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, a curare-like action may occur.

    Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir – Mint contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

    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 a 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 a nursing woman.

    Geriatric Use

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

  • 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 chronic use of phenobarbital.

    Phenobarbital may produce excitement in some patients, rather than a 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.

  • 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 a history of physical and/or psychological dependence upon drugs (see WARNINGS).

    Dependence

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

  • 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.

  • 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

  • HOW SUPPLIED

    Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir - Grape is a 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 a 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 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

    logo

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 4 OZ GRAPE

    NDC 50742-666-04
    Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    Elixir Grape Flavored
    Each 5 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 mg

    Alcohol not more than 23.8%

    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING

    Rx Only

    4 FL OZ

    Ingenus


    bottle-label-4oz-grape
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 PINT GRAPE

    NDC 50742-666-16

    Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    Elixir Grape Flavored
    Each 5 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 mg
    Alcohol not more than 23.8%
    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING

    Bulk Container-Not For Household Use

    Rx Only

    1 Pint

    Ingenus


    bottle-label-16oz-grape

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 4 OZ MINT

    NDC 50742-665-04
    Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    Elixir Mint Flavored
    Each 5 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 mg

    Alcohol not more than 23.8%
    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING

    Rx Only

    4 FL OZ
    Ingenus

    bottle-label-4oz-mint

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 PINT MINT

    NDC 50742-665-16

    Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    Elixir Mint Flavored
    Each 5 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 mg

    Alcohol not more than 23.8%

    contains color additives including FD&C Yellow No. 5 (tartrazine)
    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING

    Bulk Container - Not For Household Use

    Rx Only

    1 Pint
    Ingenus

    bottle-label-16oz-mint


  • INGREDIENTS AND APPEARANCE
    PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE 
    phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide elixir
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50742-666
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D) PHENOBARBITAL16.2 mg  in 5 mL
    HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X) HYOSCYAMINE SULFATE0.1037 mg  in 5 mL
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE0.0194 mg  in 5 mL
    SCOPOLAMINE HYDROBROMIDE (UNII: 451IFR0GXB) (SCOPOLAMINE - UNII:DL48G20X8X) SCOPOLAMINE HYDROBROMIDE0.0065 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SUCROSE (UNII: C151H8M554)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPE (Artificial and Natural Grape) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50742-666-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2021
    2NDC:50742-666-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER08/01/2021
    PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE 
    phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide elixir
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50742-665
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D) PHENOBARBITAL16.2 mg  in 5 mL
    HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X) HYOSCYAMINE SULFATE0.1037 mg  in 5 mL
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE0.0194 mg  in 5 mL
    SCOPOLAMINE HYDROBROMIDE (UNII: 451IFR0GXB) (SCOPOLAMINE - UNII:DL48G20X8X) SCOPOLAMINE HYDROBROMIDE0.0065 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SUCROSE (UNII: C151H8M554)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINT (Natural Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50742-665-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2021
    2NDC:50742-665-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER08/01/2021
    Labeler - Ingenus Pharmaceuticals, LLC (833250017)