PB Hyos Elixir

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

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.

PB Hyos Elixir

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%

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

INACTIVE INGREDIENTS:

Artificial Grape Flavor, Ethyl Alcohol, FDC Blue #1, FDC 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.

INDICATIONS 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:

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.

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 PB Hyos Elixir. It is not known whether PB Hyos Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 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 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 AND ADMINISTRATION:

The dosage of 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: For children age 2 and under, consult a physician for dosage and administration. Children ages 2 and over may be dosed every 4 to 6 hours.

HOW SUPPLIED:

PB Hyos Elixir is a purple colored, grape flavored liquid. 1 Pint (16 fl oz.) bottles NDC 49769-395-16.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

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 for:
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
Rev. 02/10 395-10

PACKAGING:

Below represents the current labeling being used:

PB HYOS 
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide elixir
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49769-395
Route of Administration ORAL DEA Schedule     
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
ALCOHOL  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
GLYCERIN  
WATER  
SACCHARIN SODIUM  
SORBITOL  
SUCROSE  
Product Characteristics
Color purple Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:49769-395-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2010 10/31/2012
Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 03/2011
 
Kylemore Pharmaceuticals, LLC



Hide
(web1)