Phenohytro

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide


Winder Laboratories Llc
Human Prescription Drug
NDC 75826-128
Phenohytro also known as Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide is a human prescription drug labeled by 'Winder Laboratories Llc'. National Drug Code (NDC) number for Phenohytro is 75826-128. This drug is available in dosage form of Elixir. The names of the active, medicinal ingredients in Phenohytro drug includes Atropine Sulfate - .0194 mg/5mL Hyoscyamine Sulfate - .1037 mg/5mL Phenobarbital - 16.2 mg/5mL Scopolamine Hydrobromide - .0065 mg/5mL . The currest status of Phenohytro drug is Active.

Drug Information:

Drug NDC: 75826-128
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Phenohytro
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Winder Laboratories Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Elixir
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ATROPINE SULFATE - .0194 mg/5mL
HYOSCYAMINE SULFATE - .1037 mg/5mL
PHENOBARBITAL - 16.2 mg/5mL
SCOPOLAMINE HYDROBROMIDE - .0065 mg/5mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 25 Jun, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 19 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Winder Laboratories LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1046787
2048017
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:451IFR0GXB
03J5ZE7KA5
F2R8V82B84
YQE403BP4D
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Anticholinergic [EPC]
Cholinergic Antagonists [MoA]
Cholinergic Muscarinic Antagonist [EPC]
Cholinergic Muscarinic Antagonists [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
DEA Schedule:CIV
This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
75826-128-04118 mL in 1 BOTTLE, PLASTIC (75826-128-04)25 Jun, 2018N/ANo
75826-128-16473 mL in 1 BOTTLE, PLASTIC (75826-128-16)25 Jun, 2018N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Phenohytro phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide phenobarbital phenobarbital hyoscyamine sulfate hyoscyamine atropine sulfate atropine scopolamine hydrobromide scopolamine glycerin alcohol water sucrose sorbitol saccharin sodium fd&c yellow no. 5 fd&c blue no. 1 mint phenohytro phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide phenobarbital phenobarbital hyoscyamine sulfate hyoscyamine atropine sulfate atropine scopolamine hydrobromide scopolamine glycerin alcohol water sucrose sorbitol saccharin sodium fd&c red no. 3 fd&c blue no. 1 grape

Indications and Usage:

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.

Warnings:

Warnings heat prostration can occur with belladonna alkaloids in high temperatures. diarrhea may be an early symptom of incomplete intestinal obstruction, particularly in patients with ileostomy or colostomy. in this instance, treatment with this drug could be harmful. phenohytro ® elixir may produce drowsiness and blurred vision. the patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be necessary for optimal effect. when phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. phenobarbital may be habit forming and should not be administered to patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence. barbiturates should be used with caution in patients with hepatic dysfunction.

General Precautions:

General use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension. belladonna alkaloids may produce a delay in gastric emptying (antral stasis), which would complicate the management of gastric ulcer. do not rely on the use of the drug in the presence of complication of biliary tract disease. theoretically, a curare-like action may occur with overdosage.

Dosage and Administration:

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:

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.

Adverse Reactions:

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, l
lc at 1-770-307-0702, or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Use in Pregnancy:

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:

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.

Description:

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

Clinical Pharmacology:

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.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals have not been performed to evaluate carcinogenic potential.

How Supplied:

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).

Information for Patients:

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.

Package Label Principal Display Panel:

Principal display panel - 16 fl. oz. bottle label - mint ndc 75826-128-16 winder ® labs phenohytro ® elixir mint flavored each 5 ml (1 teaspoonful) contains: phenobarbital, usp 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% do not use if tamper-evident seal under cap is broken or missing rx only 16 fl. oz. principal display panel - 16 fl. oz. bottle label - mint

Principal display panel - 16 fl. oz. bottle label - grape ndc 75826-127-16 winder ® labs phenohytro ® elixir grape flavored each 5 ml (1 teaspoonful) contains: phenobarbital, usp 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% do not use if tamper-evident seal under cap is broken or missing rx only 16 fl. oz. principal display panel - 16 fl. oz. bottle label - grape


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.