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Carbinoxamine Maleate Extended-Release Oral Suspension 4 mg/5mL Suspension, Extended Release, 480 mL — NDC 62542-0101-05 package photo

Carbinoxamine Maleate Extended-Release Oral Suspension 4 mg/5mL Suspension, Extended Release, 480 mL

by Neos Therapeutics, LP · 480 mL in 1 BOTTLE, PLASTIC (62542-101-05)
NDC 62542-0101-05
🏷️ FDA NDC (as labeled) 62542-101-05 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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

FDA NDC (as labeled) 62542-101-05
Product NDC 62542-101
11-digit billing NDC 62542010105
NCPDP billing unit ML — per mL (volume)
RxCUI 1374770
UNII 02O55696WH
UPC 0323594101053
Application # NDA022556
SPL Set ID 199f46e5-6288-5627-e063-6294a90ae086
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-01
Route ORAL
Dosage form SUSPENSION, EXTENDED RELEASE
Substance CARBINOXAMINE MALEATE
GPI-14 4120001015G120
GCN Seq No 070822
GCN 34474
HICL code 004483
Ingredient (HICL) Carbinoxamine Maleate
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name CARBINOXAMINE ER 4 MG/5ML SUSP
FDB brand name Carbinoxamine Maleate Er
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 62542-101-05 — 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 → 62542-0101-05. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Aminoalkyl ethers
How it works Histamine H1 Receptor 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

LabelerNeos Therapeutics, LP
Application holderAYTU BIOSCIENCE INC
FDA applicationNDA022556 (NDA AUTHORIZED GENERIC)
Labeler code62542
First marketedJun 2024
Product typeHuman Prescription Drug
Portfolio10 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.

🩺 Clinical

Label name CARBINOXAMINE ER 4 MG/5ML SUSP Ingredient Carbinoxamine Maleate
📗 Our plain-language guide HelloPharmacist
  • Carbinoxamine is an antihistamine that relieves allergy symptoms — things like a runny nose, sneezing, itchy or watery eyes, and skin reactions like hives or swelling. It also work...
  • What exactly does carbinoxamine help with?
  • Yes — drowsiness is one of the most common side effects, and it can be significant. Carbinoxamine is an older-style antihistamine that crosses into the brain, so it tends to be mor...
  • If you've been prescribed Karbinal ER or Carbinoxamine Maleate Extended-Release Oral Suspension, always shake the bottle well before measuring each dose. Use the measuring device p...
📖 Read our full Carbinoxamine guide →
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

FlavorStrawberry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII XY6UN3QB6S
    A sweetener made from corn starch that contains fructose and glucose. It sweetens the medicine to improve taste and may help preserve the product.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII 1699G8679Z
    A synthetic polymer that acts as a binder and helps hold tablet or capsule ingredients together. It may also be used to improve how the medicine dissolves or is absorbed in the digestive system.
  • 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 XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

13 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.047 $502.51 / 480 ml
Medicaid paysCMS SDUD · 12 mo $1.08 $517.58 / 480 ml
Medicare drug plans payPart D · Q2 2026 $1.02 $491.66 / 480 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $1.054 $1.047
▼ Down 1% over the last 10 months.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Carbinoxamine Maleate Extended-Release Oral Suspension 4 mg/5mLthis 62542-0101-05 Neos 480 ml $1.047 — Availability likely —
Karbinal ER 4 mg/5mL 23594-0101-01 Aytu 2 bottles — — FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2013
First FDA approval
Mar 2013
📍
2026
Currently FDA-listed
13 years listed
🛡️
2029
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2029. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 28, 2013 RLD RS ⏳ ~2.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9522191 — drug product
US 8062667 — drug product
2013 2015 2017 2019 2021 2023 2025 2027 2029
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 9522191 ↗ Drug product — Jun 15, 2027
US 8062667 ↗ Drug product — Mar 29, 2029
Common questions
Is there a generic version of CARBINOXAMINE ER 4 MG/5ML SUSP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for CARBINOXAMINE ER 4 MG/5ML SUSP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2029 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 62542-0101-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
15.8K
Units reimbursed last 4 qtrs
3.7M
Gross reimbursed last 4 qtrs
$3.96M
Avg / prescription
$250.37
Avg / unit
$1.0783
Latest quarter Q4 2025
3.7KRx
Medicaid pays / mL
$1.0783
gross reimbursed
vs
NADAC / mL
$1.0469
acquisition cost
=
Spread
+$0.0314
+3% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
21% FFS 79% MCO
Fee-for-service · 3,329 Rx Managed care · 12,487 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 307,002 units · 1,569 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 4,980 units · 12.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 5,115 units · 113 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 81,703 units · 2,259 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 2,307,956 units · 21,301 per 100k residents NC South Carolina: 7,272 units · 135 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 709,278 units · 15,507 per 100k residents LA Mississippi: 3,636 units · 124 per 100k residents MS Alabama: 245,419 units · 4,805 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
12.821,301
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 North Carolina 21,301 /100k
2 Louisiana 15,507 /100k
3 Alabama 4,805 /100k
4 Connecticut 2,259 /100k
5 New York 1,569 /100k
6 South Carolina 135 /100k
7 Mississippi 124 /100k
8 Kentucky 113 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Carbinoxamine Maleate (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Carbinoxamine Maleate. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.09M
Claims incl. refills
1.8K
Beneficiaries
1.1K
Spend / beneficiary
$949.93
Spend / claim
$621.00
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Carbinoxamine Maleate Extended-Release Oral Suspension (this brand).

Top reported reactions

Drug Toxicity14
Fatigue7
Headache7
Pain7
Unresponsive To Stimuli7
Dizziness6
Loss Of Consciousness6

Age at onset

Child2
Adolescent1
Adult15
Elderly10

Reporter sex

118 reports
Male · 27%
Female · 73%

Serious outcomes

Hospitalization21
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 13 0
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 NDCDescription Marketing startStatus
62542-0101-05 You're viewing this 480 mL in 1 BOTTLE, PLASTIC (62542-101-05) 2024-06-01 Active

📄 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 183 words ▾

1 INDICATIONS AND USAGE Carbinoxamine Maleate extended-release oral suspension is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of: Seasonal and perennial allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled Amelioration of the severity of allergic reactions to blood or plasma Carbinoxamine Maleate extended-release oral suspension is an H1 receptor antagonist indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of: Seasonal and perennial allergic rhinitis ( 1 ) Vasomotor rhinitis ( 1 ) Allergic conjunctivitis due to inhalant allergens and foods ( 1 ) Mild, uncomplicated allergic skin manifestations of urticaria and angioedema ( 1 ) Dermatographism (1) As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled ( 1 ) Amelioration of the severity of allergic reactions to blood or plasma ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Adults and Adolescents 12 years of age and older ( 2.2 ): 7.5 mL to 20 mL (6 mg to 16 mg) orally every 12 hours Pediatric patients 2 years to 11 years of age (approximately 0.2 mg/kg/day to 0.4 mg/kg/day) ( 2.3 ): 2 years to 3 years – 3.75 mL to 5 mL (3 mg to 4 mg) orally every 12 hours 4 years to 5 years – 3.75 mL to 10 mL (3 mg to 8 mg) orally every 12 hours 6 years to 11 years – 7.5 mL to 15 mL (6 mg to 12 mg) orally every 12 hours

2.1General Administration Instructions The dosage of Carbinoxamine Maleate Extended-Release Oral Suspension should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated. Administer Carbinoxamine Maleate Extended-Release Oral Suspension by the oral route only.

Measure Carbinoxamine Maleate Extended-Release Oral Suspension with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose.

Shake Carbinoxamine Maleate extended-release oral suspension well before use.

2.2Recommended Dosage for Adults and Adolescents 12 years of age and older: Administer 7.5 mL to 20 mL (6 mg to 16 mg) orally every 12 hours

2.3Recommended Dosage for Pediatric Patients 2 years to 11 years of age (approximately 0.2 mg/kg/day to 0.4 mg/kg/day): 2 years to 3 years: Administer 3.75 mL to 5 mL (3 mg to 4 mg) orally every 12 hours 4 years to 5 years: Administer 3.75 mL to 10 mL (3 mg to 8 mg) orally every 12 hours 6 years to 11 years: Administer 7.5 mL to 15 mL (6 mg to 12 mg) orally every 12 hours

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release oral suspension: 4 mg carbinoxamine maleate per 5 mL as a light beige to tan viscous suspension with strawberry-banana flavor. Extended-release oral suspension: 4 mg carbinoxamine maleate per 5 mL ( 3 )

⛔ Contraindications 94 words ▾

4 CONTRAINDICATIONS Carbinoxamine Maleate Extended-Release Oral Suspension is contraindicated in: children younger than 2 years of age because deaths have been reported in this age group [see Warnings and Precautions (5.1)]. patients who are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Carbinoxamine Maleate Extended-Release Oral Suspension [see Warnings and Precautions (5.4)]. patients who are taking monoamine oxidase inhibitors (MAOI) [see Drug Interactions (7)]. Children younger than 2 years of age (4) Patients with known hypersensitivity to the drug or any of the inactive ingredients (4) Monoamine oxidase inhibitors (MAOI) (4)

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery. (5.2) Anticholinergic actions: Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction. (5.3) Contains sodium metabisulfite, a sulfite that may cause anaphylaxis including life-threatening or less severe asthmatic episodes in susceptible individuals.

(5.4)

5.1Pediatric Mortality Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing drug products; therefore, Carbinoxamine Maleate Extended-Release Oral Suspension is contraindicated in children younger than 2 years of age.

5.2Somnolence and Impaired Mental Alertness Carbinoxamine Maleate Extended-Release Oral Suspension may produce marked drowsiness and impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Carbinoxamine Maleate Extended-Release Oral Suspension. Avoid concurrent use of Carbinoxamine Maleate Extended-Release Oral Suspension with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur.

5.3Concomitant Medical Conditions Carbinoxamine Maleate Extended-Release Oral Suspension has anticholinergic (atropine-like) properties and, therefore, should be used with caution in patients with: increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, or pyloroduodenal obstruction.

5.4Allergic Reactions due to Sulfites, including Anaphylaxis Carbinoxamine Maleate Extended-Release Oral Suspension contains sodium metabisulfite, a sulfite that may cause allergictype reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in susceptible individuals. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic individuals.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Somnolence and Impaired Mental Alertness [see Warnings and Precautions (5.2)] Allergic Reactions due to Sulfites, including Anaphylaxis [see Warnings and Precautions (5.4)] The most frequent adverse reactions include: sedation, sleepiness, dizziness, disturbed coordination, epigastic distress, and thickening of bronchial secretions. In clinical use, younger children and older adults may be particularly sensitive to adverse reactions [see Pediatric Use (8.4) and Geriatric Use (8.5)].

The following adverse reactions, listed by body system, have been identified in case reports and during the use of carbinoxamine in observational studies. Because these reactions are 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. Body as a Whole : Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat.

Cardiovascular : Hypotension, headache, palpitations, tachycardia, extrasystoles. Central Nervous System : Fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal : Anorexia, nausea, vomiting, diarrhea, constipation.

Hematologic : Hemolytic anemia, thrombocytopenia, agranulocytosis. Laboratory : Increase in uric acid levels. Respiratory : Tightness of chest and wheezing, nasal stuffiness.

Urogenital : Urinary frequency, difficult urination, urinary retention, early menses. Most common adverse reactions are: sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Neos Therapeutics at 1-855-298-8246 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 83 words ▾

7 DRUG INTERACTIONS Do not use Carbinoxamine Maleate extended-release oral suspension in patients who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Avoid use of Carbinoxamine Maleate extended-release oral suspension with alcohol and other CNS depressants (hypnotics sedatives, tranquilizers, etc.) due to additive effects. Monoamine oxidase inhibitors (MAOIs): Prolong and intensify the anticholinergic (drying) effects.

(4 and 7) Alcohol and CNS depressants (hypnotics sedatives, tranquilizers, etc.): Avoid concomitant use due to additive adverse effects. (7)

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. (8.2) Contraindicated in children younger than 2 years of age. (4 and 8.4) May cause sedation or excitation in young children. (8.4) May cause dizziness, sedation, and hypotension in elderly patients. Start elderly patients on lower doses and observe closely for confusion and over-sedation. (8.5)

8.1Pregnancy Risk Summary Published data over decades of use of antihistamines, including carbinoxamine, have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, published data specifically evaluating the risk of carbinoxamine were not found. Animal reproductive studies have not been conducted with carbinoxamine maleate.

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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary Based on the physical properties of carbinoxamine, it is likely that carbinoxamine is present in breastmilk. There are published reports of drowsiness and irritability in infants exposed to antihistamines via breast milk. There are postmarketing reports of deaths in children under 2 years of age exposed to carbinoxamine by oral administration.

There are no available data on the effects on milk production. It is not recommended to breastfeed during treatment with Carbinoxamine Maleate extended-release oral suspension [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

8.4Pediatric Use Carbinoxamine Maleate extended-release oral suspension is contraindicated in pediatric patients younger than 2 years of age because deaths have been reported in this patient population who were taking carbinoxamine-containing drug products [see Contraindications (4) and Warnings and Precautions (5.1)]. The safety and effectiveness of Carbinoxamine Maleate extended-release oral suspension in pediatric patients aged 2 years and older have been established and is based on demonstration of bioequivalence to the immediate-release reference product [see Clinical Pharmacology (12.3)].

Carbinoxamine may diminish mental alertness or produce sedation in children. Paradoxical reactions with excitation are more likely in younger children.

8.5Geriatric Use Carbinoxamine Maleate extended-release oral suspension may cause dizziness, hypotension, confusion, or over-sedation in the elderly. Start elderly patients on lower doses and observed closely.

🆘 Overdosage 112 words ▾

10 OVERDOSAGE Overdosage with carbinoxamine may cause central nervous system depression or stimulation, hallucinations, convulsions, and death. Atropine-like signs and symptoms – dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur. The treatment of overdosage consists of discontinuation of Carbinoxamine Maleate extended-release oral suspension and institution of symptomatic and supportive therapy.

Vital signs (including respiration, pulse, blood pressure, and temperature) and EKG should be monitored. Induction of vomiting is not recommended. Activated charcoal should be given and gastric lavage should be considered after ingestion of a potentially life-threatening amount of drug.

In the presence of severe anticholinergic effects, physostigmine may be useful. Vasopressors may be used to treat hypotension.

🧬 Clinical Pharmacology 174 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Carbinoxamine is an H1 receptor antagonist (antihistamine) that exhibits anticholinergic (drying) and sedative properties. Antihistamines compete with histamine for receptor sites on effector cells.

12.3Pharmacokinetics Carbinoxamine Maleate extended-release oral suspension after single-dose administration of 16 mg was bioequivalent to the reference carbinoxamine immediate-release oral solution after the administration of two doses of 8 mg six hours apart under fasting conditions. The carbinoxamine mean (SD) peak plasma concentration (Cmax) was 28.7 (5.3) ng/mL at 6.7 hours after Carbinoxamine Maleate extended-release oral suspension administration. The plasma half-life of carbinoxamine was 17.0 hours.

There was no effect of food on the pharmacokinetic parameters. Carbinoxamine Maleate extended-release oral suspension after multiple-dose administration of 16 mg every 12 hours for 8 days was bioequivalent to the reference carbinoxamine immediate-release oral solution after multiple-dose administration of 8 mg every 6 hours. The mean (SD) steady-state Cmax was 72.9 (24.4) ng/mL at 5.6 hours after Carbinoxamine Maleate extended-release oral suspension administration.

Carbinoxamine mean (SD) minimum plasma concentration at steady-state was 51.8 (20.3) ng/mL.

📦 How Supplied / Storage and Handling 71 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Carbinoxamine Maleate extended-release oral suspension contains 4 mg carbinoxamine maleate per 5 mL. It is a light beige to tan viscous suspension with strawberry banana flavor and is supplied as follows: NDC 62542-101-05 Bottles of 16 fl oz (480 mL) Store at 25ºC (77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container with child-resistant closure.

📋 Description 90 words ▾

11 DESCRIPTION Each 5 mL of Carbinoxamine Maleate extended-release oral suspension contains 4 mg carbinoxamine maleate (equivalent to 2.86 mg of carbinoxamine) complex with sodium polystyrene sulfonate. Carbinoxamine Maleate extended-release oral suspension contains the following inactive ingredients: citric acid anhydrous, strawberry-banana flavor, glycerin, high fructose corn syrup, methylparaben, modified food starch, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, triacetin, and xanthan gum.

The chemical name of carbinoxamine maleate is 2-[(4-chlorophenyl)-2- pyridinylmethoxy]-N, N-dimethylethanamine (Z)-2-butenedioate (1:1), which has the following structure: structure 1 Structure 2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62542-0100-31 · Neos 62542-0250-31 · Neos →
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.