Phenohytro Elixir

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

Phenobarbital is a barbiturate, nonselective central nervous system depressant. It is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.

Atropine Sulfate, Hyoscyamine Sulfate, and Scopolamine are belladonna alkaloids classified as anticholinergic, antimuscarinic drugs. They act to inhibit muscarinic actions of acetylcholine at postganglionic parasympathetic neuron effector sites. These drugs are also used as antispasmodics due to their anticholinergic action. They produce the effect in the body of reduced muscle spasms in the digestive or urinary tract, and reduced fluid secretions from certain glands or organs.

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.

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

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.

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.

PHENOHYTRO® ELIXIR Grape Flavored is a purple colored, grape flavored liquid.

NDC 75826-127-04 Grape Flavored in 4 oz bottles.

NDC 75826-127-16 Grape Flavored in 16 oz bottles.

PHENOHYTRO® ELIXIR Mint Flavored is a green colored, mint flavored liquid.

NDC 75826-128-04 Mint Flavored in 4 oz bottles.

NDC 75826-128-16 Mint Flavored in 16 oz bottles.

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).

Manufactured by:
Winder Laboratories, LLC.
Winder, GA 30680

70102US10

Rev. 05/18

NDC 75826-127-16
winder®
LABS

Phenohytro®
Elixir

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.

Medical Disclaimer