Label: PHENOHYTRO- phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide elixir

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 20, 2020

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    PHENOHYTRO® ELIXIR Grape Flavored

    each 5 mL (teaspoonful) oral-administered dose of elixir contains:

    Phenobarbital, USP (WARNING: may be habit forming) 16.2 mg
    Hyoscyamine Sulfate, USP0.1037 mg
    Atropine Sulfate, USP0.0194 mg
    Scopolamine Hydrobromide, USP0.0065 mg
    Alcohol not more than 23.8%

    INACTIVE INGREDIENTS

    Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial grape flavor, FD&C Red No. 3, FD&C Blue No. 1.

  • DESCRIPTION

    PHENOHYTRO® ELIXIR Mint Flavored

    each 5 mL (teaspoonful) oral-administered dose of elixir contains:

    Phenobarbital, USP (WARNING: may be habit forming)16.2 mg
    Hyoscyamine Sulfate, USP0.1037 mg
    Atropine Sulfate, USP0.0194 mg
    Scopolamine Hydrobromide, USP0.0065 mg
    Alcohol not more than 23.8%

    INACTIVE INGREDIENTS

    Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial mint flavor, FD&C Yellow No. 5, FD&C Blue No. 1.

    Phenobarbital is a barbiturate with the chemical name 2,4,6(1H,3H,5H) -Pyrimidinetrione, 5-ethyl-5-phenyl-. It has the following structural formula:

    image description

    C12H12N2O3 Chemical Structure M.W. 232.2


    Hyoscyamine sulfate is a belladonna alkaloid with the chemical name Benzeneacetic acid, α-(hydroxmethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate. It has the following structural formula:

    image description


    (C17H23NO3)2 ∙ H2SO4 ∙ 2H2O Chemical Structure M.W. 712.85

    Atropine sulfate is belladonna alkaloid with the chemical name: Benzeneacetic acid, α-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester. It has the following structural formula:

    image description

    (C34H46N2O6 ∙ H2O4S ∙ H2O Chemical Structure M.W. 694.83

    Scopolamine hydrobromide is a belladonna alkaloid with the chemical name Benezeneacetic acid, α-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo[3.31.0.2,4]non-[7-yl ester, hydrobromide, trihydrate, [7(S)-(1α,2β,4β,5α,7β)]-. It has the following structural formula:

    image description


    C17H21NO4 ∙ BrH ∙ 3H2O Chemical Structure M.W. 438.31

  • CLINICAL PHARMACOLOGY

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

    Phenobarbital is a barbiturate, nonselective central nervous system depressant. It is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.

    Atropine Sulfate, Hyoscyamine Sulfate, and Scopolamine are belladonna alkaloids classified as anticholinergic, antimuscarinic drugs. They act to inhibit muscarinic actions of acetylcholine at postganglionic parasympathetic neuron effector sites. These drugs are also used as antispasmodics due to their anticholinergic action. They produce the effect in the body of reduced muscle spasms in the digestive or urinary tract, and reduced fluid secretions from certain glands or organs.

  • INDICATIONS AND USAGE

    Based on the National Academy of Sciences-National Research Council's review of this drug and/or other information, FDA has classified the following indications as "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

    PHENOHYTRO® ELIXIR is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital produces restlessness and/or excitement.

    PHENOHYTRO® ELIXIR is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis; intestinal atony; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; hiatal hernia associated with reflux esophagitis; obstructive disease of the gastrointestinal tract; or severe ulcerative colitis.

  • WARNINGS

    Heat prostration can occur with belladonna alkaloids in high temperatures.

    Diarrhea may be an early symptom of incomplete intestinal obstruction, particularly in patients with ileostomy or colostomy. In this instance, treatment with this drug could be harmful.

    PHENOHYTRO® ELIXIR may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery.

    Phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be necessary for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.

    Phenobarbital may be habit forming and should not be administered to patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence.

    Barbiturates should be used with caution 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, and 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, a curare-like action may occur with overdosage.

    CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

    Long-term studies in animals have not been performed to evaluate carcinogenic potential.

    PREGNANCY

    PREGNANCY CATEGORY C

    Animal reproduction studies have not been conducted with PHENOHYTRO® ELIXIR. It is not known whether PHENOHYTRO® ELIXIR can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PHENOHYTRO® ELIXIR should be given to a pregnant woman only if clearly needed.

    NURSING MOTHERS

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when administering PHENOHYTRO® ELIXIR to a nursing woman.

    INFORMATION FOR PATIENTS

    Practitioners should give the following information and instructions to patients:

    • Do not increase the dose of this drug without consulting a physician.
    • Do not share this medication with others.
    • The use of this product carries with it an associated risk of psychological and/or physical dependence.
    • The use of this product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving or operating machinery.
    • Use of this product with alcohol may result in additional central nervous system depressant effects.
    • Tell your doctor or pharmacist if you also take antihistamines, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, narcotic pain relievers, or psychiatric medicines.
    • This drug may increase the risk for heatstroke because it decreases sweating. Avoid becoming overheated in hot weather, saunas, and during exercise or other strenuous activity.
  • ADVERSE REACTIONS

    Call your doctor for medical advice about side effects.

    Adverse reactions associated with anticholinergics and/or anticonvulsants are: dry mouth; tachycardia; urinary hesitancy and retention; palpitation; blurred vision; prolonged pupil dilation; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, hives and/or other dermal manifestations; decreased sweating; impotence; suppression of lactation; constipation; bloated feeling and musculoskeletal pain. Elderly patients may react with symptoms of excitement, agitation and drowsiness to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

    To report SUSPECTED ADVERSE REACTIONS, contact Winder Laboratories, LLC at 1-770-307-0702, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • 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. Call your doctor or local Poison Control Center if overdosage is suspected.

    The dosage of PHENOHYTRO® ELIXIR should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

  • DOSAGE AND ADMINISTRATION

    Adults

    One or two teaspoonfuls of PHENOHYTRO® ELIXIR three or four times a day according to conditions and severity of symptoms.

    Pediatric patients

    may be dosed every 4 to 6 hours.

    Starting Dosage
    Body Weightq4hq6h
    10 lb. (4.5 kg)0.5 mL0.75 mL
    20 lb. (9.1 kg)1.0 mL1.5 mL
    30 lb. (13.6 kg)1.5 mL2.0 mL
    50 lb. (22.7 kg)1/2 tsp3/4 tsp
    75 lb. (34 kg)3/4 tsp1 tsp
    100 lb. (45.4kg)1 tsp1 1/2 tsp
  • HOW SUPPLIED

    PHENOHYTRO® ELIXIR Grape Flavored is a purple colored, grape flavored liquid.

    NDC 17856-0125-01 Grape Flavored in 10mL 72 CUP 

    NDC 17856-0125-02 Grape Flavored in 5mL 72 CUP 

    STORAGE CONDITIONS

    AVOID FREEZING

    Store PHENOHYTRO® 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. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser.

    WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    IN THE CASE OF OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    Contains color additives, including FD&C Yellow No. 5 (tartrazine).

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP. 

    20101 N.E 16TH PLACE

    MIAMI, FL 33179

  • PRINCIPAL DISPLAY PANEL - 16 fl. oz. Bottle Label - Grape

    NDC 17856-0125-02

    Phenohytro®

    Elixir 5mL CUP 

    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
    16 fl. oz.

    image 1

    image 2

  • PRINCIPAL DISPLAY PANEL - 16 fl. oz. Bottle Label - Grape

    NDC 17856-0125-01

    Phenohytro®

    Elixir 10mL CUP 

    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
    16 fl. oz.

    image 1

  • INGREDIENTS AND APPEARANCE
    PHENOHYTRO 
    phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide elixir
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17856-0125(NDC:75826-127)
    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
    Glycerin (UNII: PDC6A3C0OX) 1981 mg  in 5 mL
    ALCOHOL (UNII: 3K9958V90M) 407 mg  in 5 mL
    WATER (UNII: 059QF0KO0R) 2119 mg  in 5 mL
    Sucrose (UNII: C151H8M554) 289 mg  in 5 mL
    Sorbitol (UNII: 506T60A25R) 895 mg  in 5 mL
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 28.9 mg  in 5 mL
    FD&C Red No. 3 (UNII: PN2ZH5LOQY) 0.075 mg  in 5 mL
    FD&C Blue No. 1 (UNII: H3R47K3TBD) 0.005 mg  in 5 mL
    Grape (UNII: 6X543N684K) 2 mg  in 5 mL
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0125-172 in 1 BOX05/20/2020
    110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:17856-0125-272 in 1 BOX05/20/2020
    25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER08/30/2018
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707repack(17856-0125) , relabel(17856-0125)