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Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/5mL; 1.5 mg/5mL Syrup, 473 mL — NDC 40032-0810-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/5mL; 1.5 mg/5mL Syrup, 473 mL — NDC 40032-810-05 (Billing 40032-0810-05)

by Novel Laboratories, Inc. · 473 mL in 1 BOTTLE

This is a package of 473 mL of Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/5mL; 1.5 mg/5mL Syrup from Novel Laboratories, Inc., marketed since Feb 2017 and currently FDA-listed. It is this product's only package size.

NDC 40032-0810-05
🏷️ FDA NDC (as labeled) 40032-810-05 billing pads the product segment with a zero
Rx only Generic On market CII ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 40032-810-05
Product NDC 40032-810
11-digit billing NDC 40032081005
RxCUI 992668
UNII NO70W886KK, 68JRS2HC1C
UPC 0340032810056
Application # ANDA203535
SPL Set ID 4050ae05-7f1a-48b7-99b9-f8db8aa02741
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule CII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-02-13
Route ORAL
Dosage form SYRUP
Substance HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
TE code (Orange Book) AA · RLD · RS
Quick answers
  • RxCUI (RxNorm): 992668
Why two NDCs? The FDA registers this code as 40032-810-05 — 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 → 40032-0810-05. 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 Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Anticholinergics, Belladonna alkaloids, semisynthetic, quaternary ammonium compounds
How it works Cholinergic Muscarinic 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.

Clinical

📖 What it is MedlinePlus · NLM

Hydrocodone is available in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone combination products are used to relieve severe pain. Other hydrocodone combination products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing. You will tak...

Read the full MedlinePlus article ↗

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.

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 systemPer mLPer 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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
40032-0810-05 You're viewing this Main listing 473 mL in 1 BOTTLE 2017-02-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/5mL; 1.5 mg/5mL 10702-0150-16 KVK-Tech, 473 ml $0.103 AA Availability likely —
Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/5mL; 1.5 mg/5mL 64950-0371-47 Genus 473 ml $0.103 AA Availability likely —
Hydromet 5 mg/5mL; 1.5 mg/5mL 00472-1030-16 Actavis 473 ml $0.103 AA Discontinued —
Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/5mL; 1.5 mg/5mL 00121-1036-40 PAI 10 cups — AA FDA listed —
Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/5mL; 1.5 mg/5mLthis 40032-0810-05 Novel 473 ml — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII BUC5I9595W
    A natural flavoring derived from cherry fruit that gives the medicine its cherry taste. It helps mask bitter drug flavors and makes the medication more pleasant to take.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.

10 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.

Manufacturer & labeler

LabelerNovel Laboratories, Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA203535 (ANDA)
Labeler code40032
First marketedFeb 2017
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio22 products on file
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.

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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~3 min read ▾

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS) See full prescribing information for complete boxed warning. Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

Reserve Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for the shortest duration that is consistent with individual patient treatment goals , monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment. [ see Warnings and Precautions ( 5.1 ) ] Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup).

Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) therapy or when used in patients at higher risk [ see Warnings and Precautions ( 5.2 ) ] . Accidental Ingestion Accidental ingestion of even one dose of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), especially by children, can result in a fatal overdose of hydrocodone [ see Warnings and Precautions ( 5.2 ) ]. Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup).

Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) [ see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.5 ) ]. Cytochrome P450 3A4 Interaction The concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) in patients taking a CYP3A4 inhibitor or inducer [ see Warnings and Precautions ( 5.7 ), Drug Interactions ( 7.2 , 7.3 ) ]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death .

Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) in patients taking benzodiazepines, other CNS depressants, or alcohol. [ see Warning and Precautions ( 5.8 ), Drug Interactions ( 7.5 ) ] Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup). The co-ingestion of alcohol with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Soluti…

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) are indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations ( 8.4 ) ]. Contraindicated in pediatric patients less than 6 years of age [see Contraindications ( 4 )].

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1 )], reserve Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) is a combination of hydrocodone, an opioid agonist, and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in adult patients 18 years of age and older.

( 1 ) Limitations of Use ( 1 ) Not indicated for pediatric patients under 18 years of age. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION

2.1Important Dosage and Administration Instructions Administer Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) by the oral route only. Always use an accurate milliliter measuring device when administering Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [ see Warnings and Precautions ( 5.5 ) ].

For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use.

Advise patients not to increase the dose or dosing frequency of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions ( 5.2 ), Overdosage ( 10 ) ]. The dosage of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [ see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.4 ) ].

2.2Recommended Dosage Adults 18 years of age and older : 5 mL of the Oral Solution (Syrup) every 4 to 6 hours as needed; not to exceed 30 mL in 24 hours.

2.3Monitoring, Maintenance, and Discontinuation of Therapy Prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for the shortest duration that is consistent with individual patient treatment goals [ see Warnings and Precautions ( 5.1 ) ] . Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [ see Warnings and Precautions ( 5.2 ) ] . Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [ see Warnings and Precautions ( 5.4 ) ].

If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [ see Warnings and Precautions ( 5.1 ) ]. Do not abruptly discontinue Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) in a physically-dependent patient [ see Drug Abuse and Dependence ( 9.3 ) ]. When a patient who has been taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) regularly and may be physically dependent no longer requires therapy with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal.

If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Adults 18 years of age and older : 5 mL Oral Solution (Syrup) every 4 to 6 hours as needed; not to exceed 30 mL in 24 hours. ( 2.2 ) Measure Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) with an accurate milliliter measuring device.

( 2.1 , 5.5 ) Do not increase the dose or dosing frequency. ( 2.1 ) Prescribe for the shortest duration consistent with treatment goals. ( 2.3 ) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology.

( 2.3 ) Reevaluate patient prior to refilling. ( 2.3 )

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Solution (Syrup) (syrup): Each 5 mL contains hydrocodone bitartrate 5 mg; and homatropine bromide 1.5 mg and available as a clear red-colored, cherry-flavor oral solution. [ see Description ( 11 ) ]. Oral Solution (Syrup): Each 5 mL contains hydrocodone bitartrate 5 mg; and homatropine methylbromide 1.5 mg. ( 3 )

⛔ Contraindications 182 words ▾

4 CONTRAINDICATIONS Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) is contraindicated for: All pediatric patients younger than 6 years of age [ see Warnings and Precautions ( 5.2 , 5.3 ), Use in Specific Populations ( 8.4 ) ]. Significant respiratory depression [see Warnings and Precautions ( 5.2 )]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.4 )].

Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.9 )]. Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) [ see Adverse Reactions ( 6 ) ]. Children younger than 6 years of age.

( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus.

( 4 ) Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup). ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy. ( 5.4 ) Activities requiring mental alertness : Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. ( 5.6 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use.

May increase intracranial pressure and obscure the clinical course of head injuries. ( 5.10 ) Seizures in patients with seizure disorders : Monitor during therapy. ( 5.11 ) Severe hypotension : Monitor during initiation of therapy.

Avoid use in patients with circulatory shock. ( 5.12 ) Adrenal insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.14 )

5.1Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) contains hydrocodone, a Schedule II controlled substance. As an opioid, Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) exposes users to the risks of addiction, abuse, and misuse [ see Drug Abuse and Dependence ( 9 ) ], which can lead to overdose and death [ see Overdosage ( 10 ) ]. Reserve Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup).

Addiction can occur at recommended dosages and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Consider these risks when prescribing or dispensing Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup). Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [ see Patient Counseling Information ( 17 ) ]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including hydrocodone, one of the active ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup). Hydrocodone produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls respiratory rhythm and may produce irregular and periodic breathing. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.

Management of respiratory depression includes discontinuation of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), depending on the patient's clinical status [ see Overdosage ( 10 )…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Addiction, abuse, and misuse [ see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.3 ) ] Life-threatening respiratory depression [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.8 ), Overdosage ( 10 )] Accidental overdose and death due to medication errors [see Warnings and Precautions ( 5.5 )] Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions ( 5.6 )] Interactions with benzodiazepines and other CNS depressants [see Warnings and Precautions (5.8), Drug Interactions ( 7.1 ), ( 7.4 )] Paralytic ileus, gastrointestinal adverse reactions [see Warnings and Precautions ( 5.9 )] Increased intracranial pressure [see Warnings and Precautions ( 5.10 )] Obscured clinical course in patients with head injuries [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Severe hypotension [see Warnings and Precautions ( 5.12 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.13 )] Adrenal insufficiency [ see Warnings and Precautions ( 5.14 ) ] The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or homatropine.

Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation. Other reactions include: Anaphylaxis : Anaphylaxis has been reported with hydrocodone, one of the ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup).

Body as a whole : Coma, death, fatigue, falling injuries, lethargy. Cardiovascular : Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush. Central Nervous System : Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor.

Dermatologic : Flushing, hyperhidrosis, pruritus, rash. Endocrine/Metabolic : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Cases of androgen deficiency have occurred with chronic use of opioids. Gastrointestinal : Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi). Genitourinary : Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.

Laboratory : Increases in serum amylase. Musculoskeletal : Arthralgia, backache, muscle spasm. Ophthalmic : Miosis (constricted pupils), visual disturbances.

Psychiatric : Agitation, anxiety, confusion, fear, dysphoria, depression. Reproductive : Hypogonadism, infertility. Respiratory : Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection.

Other : Drug abuse, drug dependence, opioid withdrawal syndrome. Hypoglycemia : Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).

Common adverse reactions include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomit…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS No specific drug interaction studies have been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup). Serotonergic Drugs : Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected.

( 7.5 ) Monoamine Oxidase Inhibitors (MAOIs) : Can potentiate the effects of hydrocodone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping an MAOI. ( 7.6 ) Muscle Relaxants : Avoid concomitant use.

( 7.7 ) Diuretics : Hydrocodone may reduce the efficacy of diuretics. Monitor for reduced effect. ( 7.8 ) Anticholinergic drugs : Concurrent use may cause paralytic ileus.

( 5.9 , 7.9 )

7.1Alcohol Concomitant use of alcohol with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) can result in an increase of hydrocodone plasma levels and potentially fatal overdose of hydrocodone. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol while on Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) therapy [ see Warnings and Precautions ( 5.8 ) Clinical Pharmacology ( 12.3 ).

7.2Inhibitors of CYP3A4 and CYP2D6 The concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) are achieved [ see Warnings and Precautions ( 5.7 ) ].

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [ see Clinical Pharmacology ( 12.3 ) ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to hydrocodone. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) while taking a CYP3A4 or CYP2D6 inhibitor. If concomitant use is necessary, evaluate patients for respiratory depression and sedation at frequent intervals.

7.3CYP3A4 Inducers The concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [ see Clinical Pharmacology ( 12.3 ) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone [ see Warnings and Precautions ( 5.7 ) ]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [ see Clinical Pharmacology ( 12.3 ) ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) in patients who are taking CYP3A4 inducers. If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy.

7.4Benzodiazepines, and Other CNS Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) in patients who are taking b…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Avoid use in pregnant women. May cause fetal harm. ( 8.1 ) Lactation : Breast-feeding not recommended. ( 8.2 ) Renal Impairment : Use with caution in patients with severe renal impairment. ( 8.6 ) Hepatic Impairment: Use with caution in patients with severe hepatic impairment. ( 8.7 )

8.1Pregnancy Risk Summary Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) are not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [ see Warnings and Precautions ( 5.13 ), Clinical Considerations ]. There are no available data with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.

Published studies with hydrocodone have reported inconsistent findings and have important methodological limitations ( see Data ). Reproductive toxicity studies have not been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup); however, studies are available with individual active ingredients or related active ingredients ( see Data ). In animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 45 times the maximum recommended human dose (MRHD) ( see Data ).

Based on the animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight.

The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [ see Warnings and Precautions ( 5.13 ) ]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.

An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Opioids, including Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor.

Monitor neonates exposed to opioids during labor for signs of excess sedation and respiratory depression. Data Human Data Hydrocodone A limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy. However, these data cannot definitely establish or exclude any drug-associated risk during pregnancy.

Methodological limitations of these observational studies include small sample size and lack of details regarding dose, duration and timing of exposure. Animal Data Reproductive toxicity studies have not been conducted with Hydrocodone Bitartr…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) are not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [ see Warnings and Precautions ( 5.13 ), Clinical Considerations ]. There are no available data with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.

Published studies with hydrocodone have reported inconsistent findings and have important methodological limitations ( see Data ). Reproductive toxicity studies have not been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup); however, studies are available with individual active ingredients or related active ingredients ( see Data ). In animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 45 times the maximum recommended human dose (MRHD) ( see Data ).

Based on the animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight.

The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [ see Warnings and Precautions ( 5.13 ) ]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.

An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Opioids, including Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor.

Monitor neonates exposed to opioids during labor for signs of excess sedation and respiratory depression. Data Human Data Hydrocodone A limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy. However, these data cannot definitely establish or exclude any drug-associated risk during pregnancy.

Methodological limitations of these observational studies include small sample size and lack of details regarding dose, duration and timing of exposure. Animal Data Reproductive toxicity studies have not been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup); however, studies are available with individual active ingredients or related active ingredients. Hydrocodone In an embryofetal development study in pregnant hamsters dosed on gestation day 8 during the period of organogenesis, hydrocodone induced cranioschisis, a malform…

🧒 Pediatric Use 136 words ▾

8.4Pediatric Use Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) is contraindicated in pediatric patients younger than 6 years of age because of life-threatening respiratory depression and death have occurred in pediatric patients who received hydrocodone [ see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ) ]. The safety and effectiveness of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) have not been established in patients younger than 18 years of age.

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) is not recommended for use in patients younger than 18 years of age because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of hydrocodone in these patients [ see Indications ( 1 ), Warnings and Precautions ( 5.3 ) ].

🧓 Geriatric Use 187 words ▾

8.5Geriatric Use Clinical studies have not been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) in geriatric populations. Use caution when considering the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) in patients 65 years of age or older. Elderly patients may have increased sensitivity to hydrocodone; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [ see Warnings and Precautions ( 5.4 ) ].

Respiratory depression is the chief risk for elderly patients treated with opioids, including Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup). Respiratory depression has occurred after large initial doses of opioids were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration [ see Warnings and Precautions ( 5.4 , 5.8 ) ]. Hydrocodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, monitor these patients closely for respiratory depression, sedation, and hypotension.

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE Clinical Presentation Hydrocodone Acute overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, hypoglycemia, circulatory collapse, cardiac arrest, and death. Hydrocodone may cause miosis, even in total darkness.

Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [ see Clinical Pharmacology ( 12.2 ) ]. Homatropine Homatropine has broad, nonspecific anticholinergic / antimuscarinic activity that similar to, although less potent than, atropine.

Overdosage of homatropine can cause mydriasis and cycloplegia (fixed and dilated pupils), dry mouth and eyes, decreased sweating, hyperthermia, flushing, headache, visual blurring, gastrointestinal symptoms, constipation, urinary retention, tachycardia and palpitations, anxiety, restlessness, agitation, hallucinations, convulsions, cardiac arrhythmias and coma. Anticholinergic agents can also precipitate acute narrow angle glaucoma. Treatment of Overdose Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) together with institution of appropriate therapy.

Give primary attention to the reestablishment of adequate respiratory exchange through provision of a patent and protected airway and the institution of assisted or controlled ventilation. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures.

Gastric emptying may be useful in removing unabsorbed drug. The opioid antagonists, naloxone and nalmefene, are specific antidotes for respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to hydrocodone overdose, administer an opioid antagonist.

An antagonist should not be administered in the absence of clinically significant respiratory depression. Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product's prescribing information.

Hemodialysis is not routinely used to enhance the elimination of hydrocodone from the body. Physostigmine may be used parenterally for the treatment of the signs and symptoms of homatropine toxicity.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Hydrocodone Hydrocodone is an opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act centrally on the cough center. In excessive doses, hydrocodone will depress respiration.

Homatropine Homatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine.

12.2Pharmacodynamics Hydrocodone Effects on the Central Nervous System Hydrocodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and to electrical stimulation. Hydrocodone causes miosis, even in total darkness.

Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Effects on the Gastrointestinal Tract and Other Smooth Muscle Hydrocodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.

Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Effects on the Cardiovascular System Hydrocodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes and sweating and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [ see Adverse Reactions ( 6 ) ].

They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [ see Adverse Reactions ( 6 ) ].

Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.

Concentration–Adverse Reaction Relationships There is a relationship between increasing hydrocodone plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions. Homatropine Homatropine methylbromide has several mild but undesirable clinical properties resulting from its antisecretory effects.

These can include: dry mouth, loss of visual accommodation, photophobia, and difficulty in urination. The extent of the above actions is dictated by dose, dose escalation, therefore, results in progressively aversive symptoms in patients.

12.3 Pharmacokinetics Absorption Following a 10 mg oral dose of hydroco…

🧬 Mechanism of Action 77 words ▾

12.1Mechanism of Action Hydrocodone Hydrocodone is an opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act centrally on the cough center. In excessive doses, hydrocodone will depress respiration.

Homatropine Homatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine.

📦 How Supplied / Storage and Handling 109 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) is available as clear red colored, cherry flavor. Each 5 mL contains 5 mg hydrocodone bitartrate and 1.5 mg homatropine methylbromide: Bottles of 16 fl oz. (473 mL) NDC 40032-810-05 Store oral solution at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed.

📋 Description 185 words ▾

11 DESCRIPTION Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), USP contains hydrocodone an opioid agonist; and Homatropine, a muscarinic antagonist. Each spoonful (5 mL) of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) contains 5 mg hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) contains: cherry flavor, citric acid, sodium citrate, FD&C Red #40, methylparaben, propylene glycol, propylparaben, purified water, soribitol solution and sucrose.

Hydrocodone Bitartrate: The chemical name for hydrocodone bitartrate is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one-tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure: C 18 H 21 NO 3 • C 4 H 6 O 6 • 21/2H 2 O 3 Homatropine Methylbromide The chemical name for homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane, 3-[(hydroxyphenyl-acetyl)oxy]-8, 8-dimethyl-,bromide,endo.

It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure: C 17 H 24 BrNO 3 Image Image

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Addiction, Abuse, and Misuse Inform patients that the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup), even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [ see Warnings and Precautions ( 5.1 ) ] . Instruct patients not to share Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) with others and to take steps to protect Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) from theft or misuse.

Important Dosing and Administration Instructions Instruct patients how to measure and take the correct dose of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup). Advise patients to measure Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage.

Advise patients to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [ see Dosage and Administration (2.1), Warnings and Precautions ( 5.5 ) ]. Advise patients not to increase the dose or dosing frequency of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions ( 5.2 ), Overdosage ( 10 ) ]. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) and that it can occur even at recommended dosages [ see Warnings and Precautions ( 5.2 ) ].

Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [ see Warnings and Precautions ( 5.2 ) ]. Instruct patients to take steps to store Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) securely and to properly dispose of unused Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) in accordance with the local state guidelines and/or regulations.

Activities Requiring Mental Alertness Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) may produce marked drowsiness [ see Warnings and Precautions ( 5.6 ) ]. Interactions with Benzodiazepines and Other Central Nervous System Depressants, Including Alcohol Inform patients and caregivers that potentially fatal additive effects may occur if Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) is used with benzodiazepines or other CNS depressants, including alcohol.

Advise patients to avoid concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) with benzodiazepines or other CNS depressants and instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter products that contain alcohol, during treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) [ see Warnings and Precautions ( 5.8 ), Drug Interactions ( 7.1 , 7.4 ) ]. Constipation Advise patients of the potential for severe constipation [ see Warnings and Precautions ( 5.9 ), Adverse Reactions ( 6 ) ].

Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup)…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Hydrocodone Bitartrate (hye'' droe koe' done bye tar' trate) and Homatropine Methylbromide (hoe mat' roe peen meth'' il broe' mide) Oral Solution (Syrup), CII What is the most important information I should know about Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup)? Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) is not for children under 18 years of age. Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) can cause serious side effects, including: Addiction, abuse and misuse.

Taking Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) or other medicines that contain an opioid can cause addiction, abuse and misuse, which can lead to overdose and death. This can happen even if you take Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems.

Do not share your Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) with other people. Keep Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) in a safe place away from children. Life-threatening breathing problems (respiratory depression) .

Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup), are taking other medicines that can cause breathing problems, have certain lung problems, are elderly, or have certain other health problems. Children are at higher risk for respiratory depression.

Breathing problems can happen even if you take Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) exactly as prescribed by your healthcare provider. Call your healthcare provider or get emergency medical help right away if anyone taking Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) has any of the symptoms below: increased sleepiness confusion difficulty breathing shallow breathing limpness Keep Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup) in a safe place away from children.

Accidental use of even 1 dose of Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup), especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. If a child accidentally takes Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup), get emergency medical help right away. Overdose and death due to medicine dosing errors .

Overdose and death can happen if you measure the wrong dose of Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup). Always use an accurate milliliter (mL) measuring device to measure the correct amount of Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup). Do not use a household teaspoon to measure your medicine.

You may accidentally take too much. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose. Breathing problems (respiratory depression) that can lead to death and opioid withdrawal can happen if you start taking or stop taking other medicines while taking Hydrocodone Bitartrate and Homatropine Methylbromide oral solution (Syrup), including: certain antibiotics certain medicines to treat a fungal infection certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C rifampin carbamazepine phenytoin Tell your healthcare provider if you take any of these medicines.

Ask your healthcare…

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

About this NDC listing & data coverage

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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?
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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.
← 40032-0794-01 · Novel 40032-0950-01 · Novel →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.