NDC 59212-0423-04 — Donnatal phenobarbital, hyoscyamine sulfate

🆔 Identity & classification

FDA NDC (as labeled) 59212-423-04

Product NDC 59212-423

11-digit billing NDC 59212042304

NCPDP billing unit ML — per mL (volume)

RxCUI 1046787, 1046924

UNII YQE403BP4D, F2R8V82B84, 451IFR0GXB, 03J5ZE7KA5

UPC 0359212423047

SPL Set ID 4dba30db-7979-455f-a225-24f0a04d744e

Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist

Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists

DEA schedule CIV

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1980-12-30

Route ORAL

Dosage form ELIXIR

Substance PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE

GPI-14 49109904051030

GPI class Donnatal

GCN Seq No 004773

GCN 74040

HICL code 035019

Ingredient (HICL) Phenobarb/Hyoscy/Atropine/Scop

HIC1 code J

Therapeutic class — broad (HIC1) Autonomic Nervous System

HIC2 code J2

Therapeutic class — intermediate (HIC2) Anticholinergics

HIC3 code J2A

Therapeutic class — specific (HIC3) Belladonna Alkaloids

AHFS code 12:08.08.00

AHFS class Antimuscarinics/Antispasmodics

FDB label name DONNATAL ELIXIR

FDB brand name Donnatal

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 59212-423-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59212-0423-04. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist

Drug family (ATC) Belladonna alkaloids, tertiary amines, Anticholinergics, Antidotes

How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAdvanz Pharma (US) Corp.

Labeler code59212

First marketedDec 1980

DEA scheduleCIV

Product typeHuman Prescription Drug

Portfolio20 products on file

🔎 All NDCs from Advanz Pharma (US) Corp.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DONNATAL ELIXIR Ingredient Phenobarb/Hyoscy/Atropine/Scop

📖 About the active ingredient MedlinePlus · NLM

General information about the ingredient itself — the description of this specific product follows below.

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 with other medicine to treat ulcers. These medicines decrease the motion of the stomach and intestines and the secretion of stomach fluids, including acid. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗

🧪 What is this product?

Donnatal is an oral elixir containing four active ingredients: phenobarbital (a barbiturate sedative), hyoscyamine sulfate and atropine sulfate (anticholinergic agents), and scopolamine hydrobromide (also an anticholinergic). These ingredients are typically combined in products intended to reduce stomach acid secretion and calm digestive tract spasms, though this formulation is marketed without an approved FDA application. The combination has been used historically for gastrointestinal discomfort, though modern alternatives are more commonly prescribed.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Purple / Green

FlavorMint

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII PN2ZH5LOQY
A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesPurified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1. Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 10 ml 473 ml

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Phenohytro 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 17856-0125-01	ATLANTIC	72 cups	—	—	FDA listed	—
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 50742-0665-04	Ingenus	118 ml	—	—	FDA listed	—
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 50742-0666-04	Ingenus	118 ml	—	—	FDA listed	—
Donnatal 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 59212-0422-04	Advanz	118 ml	—	—	FDA listed	—
Donnatal 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mLthis 59212-0423-04	Advanz	118 ml	—	—	FDA listed	—
Donnatal 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 66689-0063-10	VistaPharm,	10 cups	—	—	FDA listed	—
Phenohytro 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 75826-0127-04	Winder	118 ml	—	—	FDA listed	—
Phenohytro 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL 75826-0128-04	Winder	118 ml	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

1980

On the market since

Dec 1980

📍

2026

Currently FDA-listed

46 years listed

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
59212-0423-04 You're viewing this	118 mL in 1 BOTTLE (59212-423-04)	1980-12-30	Active
59212-0423-10	10 mL in 1 BOTTLE (59212-423-10)	1980-12-30	Active
59212-0423-16	473 mL in 1 BOTTLE (59212-423-16)	1980-12-30	Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 59212-0423-04?

NDC 59212-0423-04 contains 118 mL — 118 ml in 1 bottle.

What is the difference between NDC 59212-0423-04 and NDC 59212-0423-10?

Both are Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir — the drug itself is identical. NDC 59212-0423-04 is the 118 mL package, while NDC 59212-0423-10 is the 10 ml package.

What NDC number is used to bill for this package of Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir?

Bill NDC 59212-0423-04 — the 11-digit billing format is 59212042304. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 59212-423-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 59212-0423-04, written without dashes as 59212042304. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 59212-0423-04, the first segment (59212) is the labeler code FDA assigned to Advanz Pharma (US) Corp.; the middle segment (0423) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanz Pharma (US) Corp.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 10 ml (59212-0423-10), 473 ml (59212-0423-16). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Advanz Pharma (US) Corp. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 🧪 Inactive Ingredients 📋 Description 💬 Information for Patients

🎯 Indications and Usage 98 words ▾

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.

⏱️ Dosage and Administration 130 words ▾

DOSAGE AND ADMINISTRATION The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects. Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.

Pediatric patients: may be dosed every 4 to 6 hours. Use a pediatric dosing device or oral syringe to measure the dose. Starting Dosage Body weight Every 4 hours Every 6 hours 10 lb.

(4.5 kg) 0.5 mL 0.75 mL 20 lb. (9.1 kg) 1 mL 1.5 mL 30 lb. (13.6 kg) 1.5 mL 2 mL 50 lb.

(22.7 kg) 2.5 mL 3.75 mL 75 lb. (34 kg) 3.75 mL 5 mL 100 lb. (45.4 kg) 5 mL 7.5 mL

⛔ Contraindications 86 words ▾

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 ~1 min read ▾

WARNINGS Donnatal® Elixir can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Donnatal® Elixir. 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.

Donnatal® Elixir 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.

🤒 Adverse Reactions 183 words ▾

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 Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 34 words ▾

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.

🤰 Pregnancy 52 words ▾

Pregnancy Animal reproduction studies have not been conducted with Donnatal® Elixir. 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 ).

🧓 Geriatric Use 23 words ▾

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

🆘 Overdosage 54 words ▾

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.

🧬 Clinical Pharmacology 25 words ▾

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.

📦 How Supplied / Storage and Handling 122 words ▾

HOW SUPPLIED Donnatal® Elixir - Grape is a purple colored, grape flavored liquid. 4 fl oz (118 mL) bottles- NDC 59212-423-04. 1 Pint (473 mL) bottles- NDC 59212-423-16.

Donnatal® Elixir - Mint is a green colored, mint flavored liquid. 4 fl oz (118 mL) bottles- NDC 59212-422-04. 1 Pint (473 mL) bottles- NDC 59212-422-16.

Avoid Freezing Store Donnatal® Elixir at 20º- 25ºC (68º - 77ºF) [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 PRODUCT Manufactured for: Advanz Pharma (US) Corp. Bannockburn, IL 60015 DONNATAL ® is a registered trademark of Mercury Pharma Group Limited. Distributed by Advanz Pharma (US) Corp. under license.

Revised:11/23

🧪 Inactive Ingredients 44 words ▾

Inactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.

Inactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.

📋 Description 117 words ▾

DESCRIPTION Donnatal ® Elixir - Grape Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) 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 Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.

Donnatal ® Elixir - Mint Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) 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 Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.

💬 Information for Patients 42 words ▾

Information for Patients Donnatal® Elixir 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.

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

sedative: A substance with a calming effect that can also cause drowsiness.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

lactation: The making and release of milk from a mother's breasts after giving birth.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

mydriasis: Widening of the pupil, the dark center of the eye.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

urticaria: Raised, itchy welts on the skin, commonly called hives.

xerostomia: Dry mouth caused by too little saliva.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir, 118 mL

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