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Vitetal Elixir

Generic Name: phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide
Dosage Form: oral liquid

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.

Vitetal Elixir - Orange
CIV

Vitetal Elixir Prescribing Info

Rx Only

Description

Each Vitetal 5 mL (teaspoonful) of elixir 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 23%

INACTIVE INGREDIENTS

Ethyl Alcohol, Glycerin, Purified Water, Saccharin Sodium, Sorbitol Solution, Natural and Artificial Orange Flavor, FD & C Red #40.

Vitetal Elixir - 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
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.

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.

Vitetal 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.

Warnings

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.

Vitetal 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, 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

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Vitetal Elixir. It is not known whether Vitetal Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vitetal 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 Vitetal Elixir is administered to a nursing woman.

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. 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.

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.

Vitetal Elixir Dosage and Administration

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

Vitetal 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) 1/2 tsp 3/4 tsp
75 lb. (34 kg) 3/4 tsp 1 tsp
100 lb. (45.4 kg) 1 tsp 1 1/2 tsp

How is Vitetal Elixir Supplied

Vitetal Elixir red colored, orange flavored liquid.

 
4 fl oz (118 mL) bottles    NDC 16571-320-04.
 
1 Pint (473 mL) bottles    NDC 16571-320-16.

AVOID FREEZING

Store Vitetal 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.

Distributed by:
PACK PHARMACEUTICALS, LLC
Buffalo Grove, IL 60089

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

TO REPORT ADVERSE DRUG EVENTS CALL: (866) 562-4597

REV 09/2011

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 16571-320-16
TAMPER EVIDENT

Vitetal
Elixir CIV

Orange 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                                      23%

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

Bulk Container-
Not For Household Use

Distributed by:
PACK PHARMACEUTICALS, LLC
Buffalo Grove, IL 60089

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

PACK
PHARMACEUTICALS, LLC

Rx Only

NET: 1 PINT (473 mL)

VITETAL 
phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16571-320
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenobarbital (Phenobarbital) Phenobarbital 16.2 mg  in 5 mL
Hyoscyamine Sulfate (Hyoscyamine) Hyoscyamine Sulfate 0.1037 mg  in 5 mL
Atropine Sulfate (Atropine) Atropine Sulfate 0.0194 mg  in 5 mL
Scopolamine Hydrobromide (Scopolamine) Scopolamine Hydrobromide 0.0065 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
alcohol  
Sorbitol  
Saccharin Sodium  
Orange  
FD&C Red no. 40  
Water  
Product Characteristics
Color ORANGE Score     
Shape Size
Flavor ORANGE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:16571-320-16 473 mL in 1 BOTTLE
2 NDC:16571-320-04 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 10/01/2011
Labeler - Pack Pharmaceuticals LLC (614823875)
Revised: 09/2011
 
Pack Pharmaceuticals LLC
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