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.

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.

DESCRIPTION

PHENOHYTRO® ELIXIR Mint Flavored

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

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:

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:

(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:

(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:

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

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 formingand 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.

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.

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).