NDC 72768-7010 Phenobarbital With Belladonna Alkaloids

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide

NDC Product Code 72768-7010

NDC CODE: 72768-7010

Proprietary Name: Phenobarbital With Belladonna Alkaloids 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, 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.

NDC Code Structure

  • 72768 - Apothecon Florida, Llc
    • 72768-7010 - Phenobarbital With Belladonna Alkaloids

NDC 72768-7010-1

Package Description: 100 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Phenobarbital With Belladonna Alkaloids with NDC 72768-7010 is a a human prescription drug product labeled by Apothecon Florida, Llc. The generic name of Phenobarbital With Belladonna Alkaloids is phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1046815.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

DEA Schedule: Schedule IV (CIV) Substances What is the Drug Enforcement Administration (DEA) CIV Schedule?
The controlled substances in the CIV schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the United States.

Phenobarbital With Belladonna Alkaloids 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.


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.

  • CALCIUM STEARATE (UNII: 776XM7047L)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)

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

Labeler Name: Apothecon Florida, Llc
Labeler Code: 72768
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-11-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Phenobarbital With Belladonna Alkaloids Product Label Images

Phenobarbital With Belladonna Alkaloids 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

Description

Each Phenobarbital with Belladonna Alkaloids Tablet contains:Phenobarbital, USP..................................... 16.2 mg
Hyoscyamine Sulfate, USP...................... 0.1037 mg
Atropine Sulfate, USP .............................0.0194 mg
Scopolamine Hydrobromide, USP ...........0.0065 mg

Inactive Ingredients

Calcium Stearate, Colloidal Silicon Dioxide, Lactose, Microcrystalline Cellulose, and Pregelatinized Starch.

Clinical Pharmacology

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

Indications And Usage

Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows: "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.Final classification of the less-than-effective indications requires further investigation.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

  • Glaucoma;obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy);obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.);paralytic ileus, intestinal atony of the elderly or debilitated patient;unstable cardiovascular status in acute hemorrhage;severe ulcerative colitis especially if complicated by toxic megacolon;myasthenia gravis;hiatal hernia associated with reflux esophagitis;in patients with known hypersensitivity to any of the ingredients.Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.

Warnings

Phenobarbital with Belladonna Alkaloids Tablets can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Phenobarbital with Belladonna Alkaloids Tablets. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.Phenobarbital with Belladonna Alkaloids Tablets may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs.Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.

General

  • Use with caution in patients with:autonomic neuropathyhepatic or renal diseasehyperthyroidismcoronary heart diseasecongestive heart failurecardiac arrhythmiastachycardiahypertensionBelladonna 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, with overdosage, a curare-like action may occur.

Information For Patients

Phenobarbital with Belladonna Alkaloids Tablets may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.

Drug Interactions

Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.

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 Phenobarbital with Belladonna Alkaloids Tablets. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (see WARNINGS).

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Phenobarbital with Belladonna Alkaloids Tablets are administered to a nursing woman.

Geriatric Use

Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.

Adverse Reactions

Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations; and decreased sweating.Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital.Phenobarbital may produce excitement in some patients, rather than a sedative effect.To report SUSPECTED ADVERSE REACTIONS, contact Apothecon Florida, LLC at 1-888-514-4727 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Abuse

Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs (see WARNINGS).

Dependence

In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

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. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be used.

Dosage And Administration

The dosage of Phenobarbital with Belladonna Alkaloids Tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.Phenobarbital with Belladonna Alkaloids Tablets - Adults: One or two Phenobarbital with Belladonna Alkaloids Tablets three or four times a day according to condition and severity of symptoms.

How Supplied

  • Phenobarbital with Belladonna Alkaloids Tablets are supplied as: White, round, convex tablet debossed with 'PBA' on one side and '7' on the other side.Bottles of 100 tablets - NDC 72768-7010-1Store 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.DEA EXEMPT PRODUCTMarketed by:Apothecon Florida, LLCDavie, FL 33328Iss. 04/20

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