NDC 75826-0128-16 — Phenohytro Phenobarbital, Hyoscyamine

🆔 Identity & classification

FDA NDC (as labeled) 75826-128-16

Product NDC 75826-128

11-digit billing NDC 75826012816

NCPDP billing unit ML — per mL (volume)

RxCUI 1046787, 2048017

UNII YQE403BP4D, F2R8V82B84, 451IFR0GXB, 03J5ZE7KA5

SPL Set ID 29be31ef-108e-4b45-9ecc-b6d671da2826

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 2018-06-25

Route ORAL

Dosage form ELIXIR

Substance PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE

GPI-14 49109904051030

GPI class Phenohytro

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 PHENOHYTRO ELIXIR

FDB brand name Phenohytro

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 75826-128-16 — 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 → 75826-0128-16. 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

LabelerWinder Laboratories LLC

Labeler code75826

First marketedJun 2018

DEA scheduleCIV

Product typeHuman Prescription Drug

Portfolio14 products on file

🔎 All NDCs from Winder Laboratories LLC

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 PHENOHYTRO 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?

Phenohytro is an oral elixir containing four active ingredients: phenobarbital (a barbiturate), hyoscyamine sulfate and atropine sulfate (anticholinergic agents), and scopolamine hydrobromide (another anticholinergic). These ingredients are typically combined in products intended to address gastrointestinal cramping and spasm, with the barbiturate component added for sedative effects. This product is marketed without an approved FDA application.

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 green / purple

FlavorGrape

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.

407 mg / 5 mL 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.
0.005 mg / 5 mL 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.
0.075 mg / 5 mL UNII I753WB2F1M
FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
1981 mg / 5 mL 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.
2 mg / 5 mL UNII FV98Z8GITP
A natural flavoring from mint plants. It's added to medicines to mask bitter tastes and improve how the medicine tastes, making it easier to take.
28.9 mg / 5 mL 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.
895 mg / 5 mL 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.
289 mg / 5 mL 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.
2119 mg / 5 mL 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.

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

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: 118 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/5mL 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/5mLthis 75826-0128-16	Winder	473 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

🏛️

2018

On the market since

Jun 2018

📍

2026

Currently FDA-listed

8 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Phenohytro (this brand).

Top reported reactions

Asthma1

Blood Pressure Increased1

Dermatitis Atopic1

Disorientation1

Dry Eye1

Eye Irritation1

Injection Site Pain1

Reporter sex

Serious outcomes

Death1

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
75826-0128-04	118 mL in 1 BOTTLE, PLASTIC (75826-128-04)	2018-06-25	Active
75826-0128-16 You're viewing this	473 mL in 1 BOTTLE, PLASTIC (75826-128-16)	2018-06-25	Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 75826-0128-16?

NDC 75826-0128-16 contains 473 mL — 473 ml in 1 bottle, plastic.

What is the difference between NDC 75826-0128-16 and NDC 75826-0128-04?

Both are Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir — the drug itself is identical. NDC 75826-0128-16 is the 473 mL package, while NDC 75826-0128-04 is the 118 ml package.

What NDC number is used to bill for this package of Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir?

Bill NDC 75826-0128-16 — the 11-digit billing format is 75826012816. 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	✓ Available
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 75826-128-16, 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: 75826-0128-16, written without dashes as 75826012816. 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 75826-0128-16, the first segment (75826) is the labeler code FDA assigned to Winder Laboratories LLC; the middle segment (0128) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 Winder Laboratories LLC. 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 1 other package presentation of this same product, including 118 ml (75826-0128-04). 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?

Winder Laboratories LLC 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 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 89 words ▾

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.

⏱️ Dosage and Administration 89 words ▾

DOSAGE AND ADMINISTRATION 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 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

⛔ Contraindications 85 words ▾

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 144 words ▾

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.

🤒 Adverse Reactions 132 words ▾

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.

🤰 Pregnancy 52 words ▾

PREGNANCY 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.

🆘 Overdosage 68 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. 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.

🧬 Clinical Pharmacology 114 words ▾

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.

📦 How Supplied / Storage and Handling 151 words ▾

HOW SUPPLIED PHENOHYTRO ® ELIXIR Grape Flavored is a purple colored, grape flavored liquid. NDC 75826-127-04 Grape Flavored in 4 oz bottles. NDC 75826-127-16 Grape Flavored in 16 oz bottles.

PHENOHYTRO ® ELIXIR Mint Flavored is a green colored, mint flavored liquid. NDC 75826-128-04 Mint Flavored in 4 oz bottles. NDC 75826-128-16 Mint Flavored in 16 oz bottles.

STORAGE CONDITIONS AVOID FREEZING Store 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).

📦 Storage and Handling 93 words ▾

STORAGE CONDITIONS AVOID FREEZING Store 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).

📋 Description ~1 min read ▾

DESCRIPTION PHENOHYTRO ® ELIXIR Grape Flavored each 5 mL (teaspoonful) oral-administered dose of elixir contains: Phenobarbital, USP ( WARNING: may be habit forming) 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% INACTIVE INGREDIENTS Purified water, glycerin, sorbitol, ethyl alcohol, sucrose, sodium saccharin, artificial grape flavor, FD&C Red No. 3, FD&C Blue No. 1.

DESCRIPTION PHENOHYTRO ® ELIXIR Mint Flavored each 5 mL (teaspoonful) oral-administered dose of elixir contains: Phenobarbital, USP ( WARNING: may be habit forming) 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% INACTIVE INGREDIENTS 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: C 12 H 12 N 2 O 3 M.W. 232.2 Hyoscyamine 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: (C 17 H 23 NO 3 ) 2 ∙ H 2 SO 4 ∙ 2H 2 O M.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: (C 34 H 46 N 2 O 6 ∙ H 2 O 4 S ∙ H 2 O M.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)-(1 α ,2 β ,4 β ,5 α ,7 β )]-. It has the following structural formula: C 17 H 21 NO 4 ∙ BrH ∙ 3H 2 O M.W.

438.31 Chemical Structure Chemical Structure Chemical Structure Chemical Structure

💬 Information for Patients 139 words ▾

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.

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 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.

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

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

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.

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.

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

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.

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.

physical dependence: When the body adapts to a medicine over time, so stopping it suddenly causes uncomfortable symptoms.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

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.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

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

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

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Hyoscyamine Sulfate 00037-9001-05 Atropine Sulfate 00409-1630-10 Methscopolamine Bromide 43063-0740-01

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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.

Phenohytro Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide 16.2 mg/5mL; .1037 mg/5mL; .0194 mg/5mL; .0065 mg/5mL Elixir, 473 mL

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