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RE-PB HYOS ELIXIR (Rebel Distributors Corp)

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ELIXIR 480 mL in 1 BOTTLE (21695-594-16) Label Information

Complete RE-PB HYOS ELIXIR Information

  • DESCRIPTION

    Each 5 mL (teaspoonful) of elixir contains:

    Phenobarbital, USP ............................................. 16.2 mg
    (WARNING: may be habit forming)
    Hyoscyamine Sulfate, USP .............................. 0.1037 mg
    Atropine Sulfate, USP ..................................... 0.0194 mg
    Scopolamine Hydrobromide, USP ................... 0.0065 mg
    Alcohol not more than 23.8%

    INACTIVE INGREDIENTS:

    Artificial Grape Flavor, Ethyl Alcohol, FD and C Blue #1, FD and C Red #40, Glycerin, Purified Water USP, Sodium Saccharin,
    Sorbitol Solution 70%, and Sucrose.


  • CLINICAL PHARMACOLOGY

    This drug combination provides peripheral anticholinergic/antispasmodic action and mild sedation.


  • INDICATION AND USAGE

    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

    RE-PB Hyos 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.

    It is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis;
    intestinal atony; unstable cardiovascular status in acute hemorrhage; 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, especially in patients with ileostomy or colostomy.
    In this instance, treatment with this drug could be harmful.

    RE-PB Hyos 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 needed 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,
    with overdosage, a curare-like action may occur.

    CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
    Long-term studies in animals have not been performed to evaluate carcinogenic potential.

    PREGNANCY CATEGORY C:
    Animal reproduction studies have not been conducted with RE-PB Hyos Elixir. It is not known whether RE-PB Hyos Elixir
    can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RE-PB Hyos 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, caution
    should be exercised when RE-PB Hyos Elixir is administered to a nursing woman.


  • ADVERSE REACTIONS

    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.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


  • 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.



  • DOSAGE & ADMINISTRATION

    The dosage of RE-PB Hyos Elixir should be adjusted to the needs of the individual patient to assure
    symptomatic control with a minimum of adverse effects.

    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.

    Starting Dosage



    Body Weight
    q4h q6h
    10 lb. (4.5 kg)
    0.5 mL
    0.75 mL
    20 lb. (9.1 kg)
    1.0 mL
    1.5 mL
    30 lb. (13.6 kg)
    1.5 mL
    2.0 mL
    50 lb. (22.7 kg)
    1/2 tsp
    3/4 tsp
    75 lb. (34 kg)
    3/4 tsp
    1 tsp
    100 lb. (45.4kg)
    1 tsp
    1 1/2 tsp







  • HOW SUPPLIED

    RE-PB Hyos Elixir is a purple colored, grape flavored liquid.

    NDC 21695-594-16 in bottles of 16 oz.

    WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL
    OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.


    Manufactured by:
    Great Southern Laboratories

    Houston, TX  77099-3405

    Manufactured for:
    River’s Edge Pharmaceuticals, LLC
    Suwanee, GA 30024

    Repackaged by: 
    Rebel Distributors Corp

    Thousand Oaks, CA 91320


  • Principal Display Panel

    Belladonna Phenobarbital


  • INGREDIENTS AND APPEARANCE
    RE-PB HYOS ELIXIR 
    belladonna alkaloids w/ phenobarbital elixir
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-594(NDC:68032-395)
    Route of Administration ORAL DEA Schedule CIV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D) PHENOBARBITAL 16.2 mg  in 5 mL
    HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X) HYOSCYAMINE SULFATE 0.1037 mg  in 5 mL
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE 0.0194 mg  in 5 mL
    SCOPOLAMINE HYDROBROMIDE (UNII: 451IFR0GXB) (SCOPOLAMINE - UNII:DL48G20X8X) SCOPOLAMINE HYDROBROMIDE 0.0065 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color purple Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21695-594-16 480 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 10/20/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distributors Corp 118802834 RELABEL, REPACK