NDC 68151-0607 Donnatal

NDC Product Code 68151-0607

NDC CODE: 68151-0607

Proprietary Name: Donnatal 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: 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product contains several medications: belladonna alkaloids (made up of the drugs hyoscyamine, atropine, and scopolamine) and phenobarbital. Belladonna alkaloids help to reduce the symptoms of stomach and intestinal cramping. They work by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines. Belladonna alkaloids belong to a class of drugs known as anticholinergics/antispasmodics. Phenobarbital helps to reduce anxiety. It acts on the brain to produce a calming effect. Phenobarbital belongs to a class of drugs known as barbiturate sedatives.

NDC Code Structure

  • 68151 - Carilion Materials Management

NDC 68151-0607-1

Package Description: 1 TABLET in 1 PACKAGE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Donnatal with NDC 68151-0607 is a product labeled by Carilion Materials Management. The generic name of Donnatal is . The product's dosage form is and is administered via form.

Labeler Name: Carilion Materials Management

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.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CALCIUM STEARATE (UNII: 776XM7047L)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Labeler Information

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

Labeler Name: Carilion Materials Management
Labeler Code: 68151
Start Marketing Date: 05-07-2008 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: 12-31-2018 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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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Information for Patients

Belladonna Alkaloid Combinations and Phenobarbital

Belladonna Alkaloid Combinations and Phenobarbital is pronounced as (bell a don' a) (fee noe bar' bi tal)

Why is belladonna alkaloid combinations and phenobarbital medication prescribed?
Belladonna alkaloid combinations and phenobarbital are used to relieve cramping pains in conditions such as irritable bowel syndrome and spastic colon. They also are used...
[Read More]

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Donnatal Product Label Images

Donnatal 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 Donnatal® Tablet contains:Phenobarbital, USP....................................... 16.2 mgHyoscyamine Sulfate, USP...................... 0.1037 mgAtropine Sulfate, USP ...............................0.0194 mgScopolamine Hydrobromide, USP ...........0.0065 mgINACTIVE INGREDIENTS: Anhydrous Lactose, Calcium Stearate, ColloidalSilicon Dioxide, Corn Starch, and Microcrystalline Cellulose.

Inactive Ingredients

Anhydrous Lactose, Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose

Clinical Pharmacology

This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital toprovide 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 otherinformation, 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 SHOWNCONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF ADUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

Contraindications

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

Warnings

In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever andheatstroke due to decreased sweating).Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy orcolostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.Donnatal® may produce drowsiness or blurred vision. The patient should be warned, should these occur, not toengage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not toperform hazardous work.Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimaleffect. 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 tothose 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 inpatients with hepatic dysfunction.

Precautions

Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heartdisease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the managementof 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.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

PREGNANCY CATEGORY CAnimal reproduction studies have not been conducted with Donnatal®. It is not known whether Donnatal® can causefetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal® should be given toa 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, cautionshould be exercised when Donnatal® is administered to a nursing woman.

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 dermalmanifestations; and decreased sweating. Acquired hypersensitivity to barbituates consists chiefly in allergic reactionsthat occur especially in persons who tend to have asthma, urticaria, angiodema and similar conditions. Hypersensitivityreactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematousdermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may becaused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and markeddegenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has beenassociated with the chronic use of phenobarbital. Elderly patients may react with symptoms of excitement, agitation,drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produceexcitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawalmay produce delirium or convulsions.

Dosage And Administration

The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with aminimum of adverse effects.Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severityof symptoms.

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 gastriclavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine orbethanechol chloride, should be used.

How Supplied

NDC:68151-0607-1 in a PACKAGE of 1 TABLETS

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