PHENOHYTRO- phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide_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.

Excipients: INACTIVE INGREDIENTS
Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial grape flavor, FD&C Red No. 3, FD&C Blue No. 1.
INACTIVE INGREDIENTS
Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial mint flavor, FD&C Yellow No. 5, FD&C Blue No. 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. 2 Hyoscyamine sulfate is a belladonna alkaloid with the chemical name Benzeneacetic acid, alpha-(hydroxmethyl)-, 8-methyl-8-azabicyclo[3. 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. 85 Atropine sulfate is belladonna alkaloid with the chemical name: Benzeneacetic acid, alpha-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3. 1]oct-3-yl ester. It has the following structural formula: (C34H46N2O6 ∙ H2O4S ∙ H2O Chemical Structure M. 83 Scopolamine hydrobromide is a belladonna alkaloid with the chemical name Benezeneacetic acid, alpha-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo[3. 2,4]non-[7-yl ester, hydrobromide, trihydrate, [7(S)-(1alpha,2beta,4beta,5alpha,7beta)]-. It has the following structural formula: C17H21NO4 ∙ BrH ∙ 3H2O Chemical Structure M. 31 image description image description image description image description.

Based on the National Academy of Sciences-National Research Council's 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 A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES, OR PREVENT COMPLICATIONS.

DOSAGE AND ADMINISTRATION
One or two teaspoonfuls of PHENOHYTRO registered may be dosed every 4 to 6 hours. Starting Dosage Body Weight q4h q6h 10 lb. 75 mL 20 lb. 7 kg) 1/2 tsp 3/4 tsp 75 lb. (34 kg) 3/4 tsp 1 tsp 100 lb. 4kg) 1 tsp 1 1/2 tsp.
Adults
One or two teaspoonfuls of PHENOHYTRO registered

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 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. 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.

PHENOHYTRO registered PHENOHYTRO registered

PREGNANCY
Animal reproduction studies have not been conducted with PHENOHYTRO registered registered registered
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 registered
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. (45.4kg) 1 tsp 1 1/2 tsp

AVOID FREEZING Store PHENOHYTRO registered 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).

each 5 mL (teaspoonful) oral-administered dose of elixir contains: Phenobarbital, USP ( WARNING: 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% Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial mint flavor, FD&C Yellow No. 5, FD&C Blue No. 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. 2 Hyoscyamine sulfate is a belladonna alkaloid with the chemical name Benzeneacetic acid, alpha-(hydroxmethyl)-, 8-methyl-8-azabicyclo[3. 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. 85 Atropine sulfate is belladonna alkaloid with the chemical name: Benzeneacetic acid, alpha-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3. 1]oct-3-yl ester. It has the following structural formula: (C34H46N2O6 ∙ H2O4S ∙ H2O Chemical Structure M. 83 Scopolamine hydrobromide is a belladonna alkaloid with the chemical name Benezeneacetic acid, alpha-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo[3. 2,4]non-[7-yl ester, hydrobromide, trihydrate, [7(S)-(1alpha,2beta,4beta,5alpha,7beta)]-. It has the following structural formula: C17H21NO4 ∙ BrH ∙ 3H2O Chemical Structure M. 31 image description image description image description image description.

ATLANTIC BIOLOGICALS CORP.

PHENOHYTRO- phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide_elixir Product manual source documgent