Label: DONNATAL- phenobarbital elixir elixir

  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 3, 2013

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    Each Donnatal(r) 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

    Artificial Grape Flavor, FD and C Blue #1, FD and C Red #3, Ethyl Alcohol, Glycerin, Purified Water, Saccharin Sodium, Sorbitol, and Sucrose.


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


    Based on a review of this drug by the National Academy of Sciences-National Research Council 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.


    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.

    Donnatal® Elixir is contraindicated 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.


    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.

    Donnatal® 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.



    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.



    Animal reproduction studies have not been conducted with Donnatal® Elixir. It is not known whether Donnatal®

    Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal® 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 Donnatal® Elixir is administered to a nursing woman.


    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. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations 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.


    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.


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

    Donnatal® 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.

    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) ½ tsp ¾ tsp

    75 lb. (34 kg) ¾ tsp 1 tsp

    100 lb. (45.4 kg) 1 tsp 1½ tsp



    Donnatal® Elixir is a purple colored, grape flavored liquid.

    4 fl oz (118 mL) bottles NDC 66213-423-04.

    1 Pint (473 mL) bottles NDC 66213-423-16.


    Store Donnatal® 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.


    Example bottle label

    example bottle lable

    phenobarbital elixir elixir
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66213-423
    Route of AdministrationORAL
    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
    Scopolamine hydrobromide (UNII: 451IFR0GXB) (Scopolamine - UNII:DL48G20X8X) Scopolamine hydrobromide0.0065 mg  in 5 mL
    Atropine sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I) Atropine sulfate0.0194 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX) 2.007 g  in 5 mL
    alcohol (UNII: 3K9958V90M) .4158 g  in 5 mL
    water (UNII: 059QF0KO0R) 2.1432 g  in 5 mL
    sucrose (UNII: C151H8M554) .2925 g  in 5 mL
    sorbitol (UNII: 506T60A25R) .9068 g  in 5 mL
    saccharin sodium (UNII: SB8ZUX40TY) .02925 g  in 5 mL
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Red No. 3 (UNII: PN2ZH5LOQY)  
    GRAPE (UNII: 6X543N684K) .041 g  in 5 mL
    Product Characteristics
    FlavorGRAPE (Artificial grape) Imprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66213-423-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2009
    Labeler - PBM Pharmaceuticals Inc. (785470050)
    Registrant - IriSys, Inc. (959205568)
    NameAddressID/FEIBusiness Operations
    IriSys, Inc.959205568manufacture(66213-423)