ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Call your doctor for medical advice about side effects. 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 exctextent, agitation and drowsiness to even small doses of the drug. Phenobarbital may produce exctextent in some patients, rather than sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.To report SUSPECTED ADVERSE REACTIONS, contact Winder Laboratories, LLC at 1-770-307-0702, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY. Long-term studies in animals have not been performed to evaluate carcinogenic potential.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. This drug combination provides phenobarbital combined with belladonna alkaloids in specific, fixed ratio to provide anticholinergic/antispasmodic action and mild sedation.Phenobarbital is barbiturate, nonselective central nervous system depressant. It is primarily used as 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. PHENOHYTRO(R) 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 exctextent.PHENOHYTRO(R) 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 SECTION.

DESCRIPTION. PHENOHYTRO(R) ELIXIR Grape Flavored. each mL (teaspoonful) oral-administered dose of elixir contains:Phenobarbital, USP (WARNING: may be habit forming)16.2 mgHyoscyamine Sulfate, USP0.1037 mgAtropine Sulfate, USP0.0194 mgScopolamine Hydrobromide, USP0.0065 mgAlcohol not more than 23.8%. INACTIVE INGREDIENTS. Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial grape flavor, FD&C Red No. 3, FD&C Blue No. 1.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Adults. One or two teaspoonfuls of PHENOHYTRO(R) ELIXIR three or four times day according to conditions and severity of symptoms.. Pediatric patients. may be dosed every to hours.Starting DosageBody Weightq4hq6h10 lb. (4.5 kg)0.5 mL0.75 mL20 lb. (9.1 kg)1.0 mL1.5 mL30 lb. (13.6 kg)1.5 mL2.0 mL50 lb. (22.7 kg)1/2 tsp3/4 tsp75 lb. (34 kg)3/4 tsp1 tsp100 lb. (45.4kg)1 tsp1 1/2 tsp.

GENERAL PRECAUTIONS SECTION.

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 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, curare-like action may occur with overdosage.

HOW SUPPLIED SECTION.

HOW SUPPLIED. PHENOHYTRO(R) ELIXIR Grape Flavored is 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 FREEZINGStore PHENOHYTRO(R) ELIXIR at 20 25C (68 77F) [see USP Controlled Room Temperature].Protect from light and moisture.Dispense in tight, light-resistant container as defined in the USP using child-resistant closure. Use safety closures when dispensing this product unless otherwise directed by 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 POISON CONTROL CENTER IMMEDIATELY.Contains color additives, including FD&C Yellow No. (tartrazine).

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Based on the National Academy of Sciences-National Research Councils review of this drug 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 DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES, OR PREVENT COMPLICATIONS.

INFORMATION FOR PATIENTS SECTION.

INFORMATION FOR PATIENTS. Practitioners should give the following information and instructions to patients:Do not increase the dose of this drug without consulting 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.. Do not increase the dose of this drug without consulting 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.

NURSING MOTHERS SECTION.

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(R) ELIXIR to nursing woman.

OVERDOSAGE SECTION.

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(R) ELIXIR should be adjusted to the needs of the individual patient to assure symptomatic control with minimum of adverse effects.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 16 fl. oz. Bottle Label Grape. NDC 17856-0125-02Phenohytro(R) Elixir 5mL CUP Grape FlavoredEach mL (1 teaspoonful) contains:Phenobarbital, USP 16.2 mgHyoscyamine Sulfate, USP 0.1037 mgAtropine Sulfate, USP 0.0194 mgScopolamine Hydrobromide, USP 0.0065 mgAlcohol not more than 23.8%DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSINGRx Only16 fl. oz.. image 1. image 2.

PRECAUTIONS SECTION.

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 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, 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(R) ELIXIR. It is not known whether PHENOHYTRO(R) ELIXIR can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. PHENOHYTRO(R) ELIXIR should be given to 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(R) ELIXIR to 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 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.. Do not increase the dose of this drug without consulting 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.

PREGNANCY SECTION.

PREGNANCY. PREGNANCY CATEGORY C. Animal reproduction studies have not been conducted with PHENOHYTRO(R) ELIXIR. It is not known whether PHENOHYTRO(R) ELIXIR can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. PHENOHYTRO(R) ELIXIR should be given to pregnant woman only if clearly needed.

STORAGE AND HANDLING SECTION.

STORAGE CONDITIONS. AVOID FREEZINGStore PHENOHYTRO(R) ELIXIR at 20 25C (68 77F) [see USP Controlled Room Temperature].Protect from light and moisture.Dispense in tight, light-resistant container as defined in the USP using child-resistant closure. Use safety closures when dispensing this product unless otherwise directed by 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 POISON CONTROL CENTER IMMEDIATELY.Contains color additives, including FD&C Yellow No. (tartrazine).

TERATOGENIC EFFECTS SECTION.

PREGNANCY CATEGORY C. Animal reproduction studies have not been conducted with PHENOHYTRO(R) ELIXIR. It is not known whether PHENOHYTRO(R) ELIXIR can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. PHENOHYTRO(R) ELIXIR should be given to pregnant woman only if clearly needed.

WARNINGS SECTION.

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(R) 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 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 forming and should not be administered to patients who are susceptible to addiction or to those with history of physical and/or psychological drug dependence.Barbiturates should be used with caution in patients with hepatic dysfunction.