NDC 17856-0123 Phenohytro

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide

NDC Product Code 17856-0123

NDC Code: 17856-0123

Proprietary Name: Phenohytro What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 17856 - Atlantic Biologicals Corp.
    • 17856-0123 - Phenohytro

NDC 17856-0123-1

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 5 mL in 1 CUP, UNIT-DOSE

NDC 17856-0123-2

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 10 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Phenohytro with NDC 17856-0123 is a a human prescription drug product labeled by Atlantic Biologicals Corp.. The generic name of Phenohytro is phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide. The product's dosage form is elixir and is administered via oral form.

Labeler Name: Atlantic Biologicals Corp.

Dosage Form: Elixir - A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Phenohytro Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENOBARBITAL 16.2 mg/5mL
  • HYOSCYAMINE SULFATE .1037 mg/5mL
  • ATROPINE SULFATE .0194 mg/5mL
  • SCOPOLAMINE HYDROBROMIDE .0065 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • SUCROSE (UNII: C151H8M554)
  • SORBITOL (UNII: 506T60A25R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MINT (UNII: FV98Z8GITP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
  • Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

* Please review the disclaimer below.

Phenohytro Product Label Images

Phenohytro Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only

DISTRIBUTED BY:ATLANTIC BIOLOGICALS CORP.20101 N.E 16TH PLACEMIAMI, FL 33179

Phenohytro® Elixir Grape Flavored

Each 5 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.

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:C12H12N2O3M.W. 232.2Hyoscyamine 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 ∙ 2H2OM.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 ∙ H2OM.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 ∙ 3H2OM.W. 438.31

Phenohytro® Elixir Mint Flavored

Each 5 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%

Clinical Pharmacology

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.

Indications And Usage

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.

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.

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 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.

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 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.

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 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.

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.

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.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

How Supplied

PHENOHYTRO® ELIXIR Mint Flavored is a green colored, mint flavored liquid.NDC 17856-0123-01 Mint Flavored  5mL Cup 72NDC 17856-0123-02 Mint Flavored  10mL Cup 72

Storage Conditions

AVOID FREEZINGStore 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).

* Please review the disclaimer below.

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