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Levocetirizine Dihydrochloride 5 mg Tablet, Film Coated, 30-count — NDC 10135-0639-30 package photo

Levocetirizine Dihydrochloride 5 mg Tablet, Film Coated, 30-count

by Marlex Pharmaceuticals Inc · 30 TABLET, FILM COATED in 1 BOTTLE (10135-639-30)
NDC 10135-0639-30
🏷️ FDA NDC (as labeled) 10135-639-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.1730/unit — full pricing hub ↓
Also comes in: 90 tablets 10135-0639-90
Rx only Generic 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) 10135-639-30
Product NDC 10135-639
11-digit billing NDC 10135063930
NCPDP billing unit EA — each (per item)
RxCUI 855172
UNII SOD6A38AGA
UPC 0310135639304, 0310135639908
Application # ANDA202046
SPL Set ID f5d8d6a6-6455-430b-8923-090e1ca2ae3b
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-09-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
GPI-14 41550027100320
GPI class Levocetirizine Dihydrochloride
GCN Seq No 048920
GCN 14901
HICL code 022959
Ingredient (HICL) Levocetirizine Dihydrochloride
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2Q
Therapeutic class — specific (HIC3) Antihistamines - 2Nd Generation
AHFS code 04:08.00.00
AHFS class Second Generation Antihistamines
FDB label name LEVOCETIRIZINE 5 MG TABLET
FDB brand name Levocetirizine Dihydrochloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 10135-639-30 — 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 → 10135-0639-30. 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) Piperazine derivatives
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

LabelerMarlex Pharmaceuticals Inc
Application holderMICRO LABS LTD INDIA
FDA applicationANDA202046 (ANDA)
Labeler code10135
First marketedSep 2018
Product typeHuman Prescription Drug
Portfolio30 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 LEVOCETIRIZINE 5 MG TABLET Ingredient Levocetirizine Dihydrochloride
📖 What it is MedlinePlus · NLM

Levocetirizine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes It is also used to treat symptoms of urticaria (hives). Levocetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's an antihistamine used to relieve the classic allergy symptoms — runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat — caused by seasonal hay fever o...
  • What exactly is levocetirizine used for?
  • It can, yes — drowsiness is the most commonly reported side effect and it's more likely at higher doses. Many people tolerate it fine, but until you know how it affects you, it's s...
  • Yes, you can take it with or without food — either way works. If you take it with a high-fat meal, it may take a little longer to kick in and the peak level in your blood may be sl...
📖 Read our full Levocetirizine 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

Color White
ShapeOval
ImprintI;12
Size8 mm
ScoringScored — splits in 2
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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

7 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 eachPer 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 · Q2 2026 $0.1730 $5.19 / 30 tablets
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
Levocetirizine Dihydrochloride 5 mg 00093-7701-98 Teva 90 tablets $0.052 AB Availability likely —
Levocetirizine Dihydrochloride 5 mg 68462-0346-90 Glenmark 90 tablets $0.052 AB Availability likely —
Levocetirizine Dihydrochloride 5 mg 69367-0238-09 Westminster 90 tablets $0.052 AB Availability likely —
Allergy Relief 5 mg 46122-0531-05 AMERISOURCEBERGEN 35 tablets $0.220 — Availability likely —
24HR Allergy Relief 5 mg 70000-0362-01 LEADER/ 5 tablets $0.220 — Availability likely —
good sense levocetirizine 5 mg 00113-0241-01 L. 35 tablets — — FDA listed —
allergy relief 5 mg 00363-3901-01 Walgreen 35 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 00363-5529-10 Walgreens 5 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 00615-8565-39 NCS 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mgthis 10135-0639-30 Marlex 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 11673-0847-16 Target 80 tablets — — FDA listed —
allergy relief 5 mg 11822-0241-00 Rite 35 tablets — — Discontinued —
levocetirizine dihydrochloride 5 mg 11822-5252-01 Rite 120 tablets — — FDA listed —
Allergy Relief 5 mg 21130-0732-10 Albertsons 5 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 30142-0717-16 KROGER 80 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 31722-0551-05 Camber 500 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 33342-0200-07 Macleods 30 tablets — AB FDA listed —
Topcare All Day Allergy 5 mg 36800-0241-01 Topco 35 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 37808-0126-10 HEB 5 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 41163-0938-35 United 35 tablets — — FDA listed —
Xyzal Allergy 24HR 5 mg 41167-3510-00 Chattem, 10 tablets — — FDA listed —
Xyzal Allergy 24HR 5 mg 41167-3511-02 Chattem, 20 tablets — — FDA listed —
Xyzal Allergy 24HR 5 mg 41167-3513-04 Chattem, 90 tablets — — FDA listed —
Xyzal 5 mg 41167-5803-09 Chattem, 90 tablets — — FDA listed —
Allergy Relief 5 mg 41250-0488-01 Meijer 35 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 42543-0712-03 Vensun 300 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 42571-0122-05 Micro 500 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 42571-0312-11 Micro 1000 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 43063-0479-30 PD-Rx 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 43598-0735-22 Dr. 55 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 43598-0810-76 Dr. 80 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 49035-0492-35 Walmart 35 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 50090-1430-00 A-S 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 50090-6979-00 A-S 90 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 50228-0136-10 ScieGen 1000 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 51407-0892-90 Golden 90 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 51655-0148-52 Northwind 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 51655-0564-52 Northwind 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 55111-0282-01 Dr.Reddy's 100 tablets — AB FDA listed —
DG Health Allergy Relief 5 mg 55910-0241-46 Dolgencorp, 1 tablet — — FDA listed —
levocetirizine dihydrochloride 5 mg 63187-0663-30 Proficient 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 63629-8500-01 Bryant 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 63868-0473-35 Chain 35 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 68071-2406-09 NuCare 90 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 68071-3726-09 NuCare 90 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 68071-3841-09 NuCare 90 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 68071-5107-09 NuCare 90 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 68196-0406-20 SAM'S 200 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 68391-0955-11 BJWC 55 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 68788-7934-01 Preferred 100 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 68788-8810-01 Preferred 100 tablets — AB FDA listed —
Allery Relief 24HR 5 mg 69168-0451-06 Allegiant 120 tablets — — FDA listed —
Levocetirizine dihydrochloride 5 mg 69230-0321-01 Camber 10 tablets — — FDA listed —
levocetirizine dihydrochloride 5 mg 69842-0761-10 CVS 5 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 71205-0210-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71205-0476-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71205-0988-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71335-0418-01 Bryant 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71335-0789-01 Bryant 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 71335-0940-01 Bryant 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 71335-1305-01 Bryant 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 71335-1952-01 Bryant 30 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 71335-2283-01 Bryant 10 tablets — AB FDA listed —
levocetirizine dihydrochloride 5 mg 72162-1525-03 Bryant 30 tablets — AB FDA listed —
basic care allergy relief 5 mg 72288-0241-27 Amazon.com 80 tablets — — FDA listed —
Curist Allergy Relief 5 mg 72559-0021-05 Little 90 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 72789-0023-30 PD-Rx 30 tablets — AB FDA listed —
Allergy Relief 5 mg 73581-0201-80 YYBA 180 tablets — — FDA listed —
Allergy Relief 24HR 5 mg 76168-0501-10 VELOCITY 10 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 82804-0204-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 82804-0232-30 Proficient 30 tablets — AB FDA listed —
Levocetirizine Dihydrochloride 5 mg 85766-0152-35 Sportpharm 35 tablets — — FDA listed —
Levocetirizine Dihydrochloride 5 mg 85786-0206-30 Farmacias 15 tablets — — FDA listed —
Allergy Relief 5 mg 72288-0784-27 Amazon.com 80 tablets — — 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

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 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.

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

Medicare Part D (outpatient prescription) spending for Levocetirizine Dihydrochloride — the program that covers self-administered drugs. 11 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 Levocetirizine Dihydrochloride. 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
$7.68M
Claims incl. refills
641.9K
Beneficiaries
464.6K
Spend / beneficiary
$16.53
Spend / claim
$11.97
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
10135-0639-30 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (10135-639-30) 2018-09-01 Active
10135-0639-90 90 TABLET, FILM COATED in 1 BOTTLE (10135-639-90) 2018-09-01 Active

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

Pack size FAQ

What quantity is in NDC 10135-0639-30?
NDC 10135-0639-30 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 10135-0639-30 and NDC 10135-0639-90?
Both are Levocetirizine Dihydrochloride 5 mg Tablet, Film Coated — the drug itself is identical. NDC 10135-0639-30 is the 30-count package, while NDC 10135-0639-90 is the 90 tablets package.
What NDC number is used to bill for this package of Levocetirizine Dihydrochloride 5 mg Tablet, Film Coated?
Bill NDC 10135-0639-30 — the 11-digit billing format is 10135063930. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 10135-639-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 10135-0639-30, written without dashes as 10135063930. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 10135-0639-30, the first segment (10135) is the labeler code FDA assigned to Marlex Pharmaceuticals Inc; the middle segment (0639) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Marlex Pharmaceuticals Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 90 tablets (10135-0639-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Marlex Pharmaceuticals Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 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
🎯 Indications and Usage 98 words ▾

1 INDICATIONS AND USAGE Levocetirizine dihydrochloride is a histamine H 1 -receptor antagonist indicated for: The relief of symptoms associated with perennial allergic rhinitis ( 1.1 ) The treatment of the uncomplicated skin manifestations of chronic idiopathicurticaria ( 1.2 )

1.1Perennial Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 years of age and older.

1.2Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablet are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Levocetirizine dihydrochloride is available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption. Chronic Idiopathic Urticaria ( 2.2 ) Adults and children 12 years of age and older: 5 mg once daily in the evening Children 6 to 11 years of age: 2.5 mg once daily in the evening Renal Impairment Adjust the dose in patients 12 years of age and older with decreased renal function ( 12.3 )

2.2Chronic Idiopathic Urticaria Adults and Children 12 Years of Age and Older The recommended dose of levocetirizine dihydrochloride tablet is 5 mg once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening. Children 6 to 11 Years of Age The recommended dose of levocetirizine dihydrochloride tablet is 2.5 mg (1/2 tablet) once daily in the evening.

The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology ( 12.3 ) ] Dose Adjustment for Renal and Hepatic Impairment In adults and children 12 years of age and older with: Mild renal impairment (creatinine clearance [CL CR ] = 50 to 80 mL/min): a dose of 2.5 mg once daily is recommended; Moderate renal impairment (CL CR = 30 to 50 mL/min): a dose of 2.5 mg once every other day is recommended; Severe renal impairment (CL CR = x10 to 30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended; End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets.

No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

💊 Dosage Forms and Strengths 51 words ▾

3 DOSAGE FORMS AND STRENGTHS Levocetirizine dihydrochloride tablets, USP are white to off white, oval shaped biconvex film coated tablet debossed with ‘I’ and ‘12’ on one side and score line on the other side and contain 5 mg levocetirizine dihydrochloride. Immediate release breakable (scored) tablets, 5 mg ( 3 )

⛔ Contraindications 145 words ▾

4 CONTRAINDICATIONS The use of levocetirizine dihydrochloride tablets are contraindicated in: Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets or to cetirizine ( 4.1 ) Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis ( 4.2 ) Children 6 months to 11 years of age with renal impairment ( 4.3 )

4.1Patients with known hypersens itivity Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions ( 6.2 ) ].

4.2Patients with end- s tage renal disease Patients with end-stage renal disease (CL CR < 10 mL/min) and patients undergoing hemodialysis

4.3Pediatric patients with impaired renal function Children 6 months to 11 years of age with impaired renal function

⚠️ Warnings and Cautions 204 words ▾

5 WARNINGS AND PRECAUTIONS Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking levocetirizine dihydrochloride ( 5.1 ). Avoid concurrent use of alcohol or other central nervous system depressants with levocetirizine dihydrochloride ( 5.1 ). Use with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia).

Discontinue levocetirizine dihydrochloride if urinary retention occurs ( 5.2 ).

5.1Somnolence In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with levocetirizine dihydrochloride. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride. Concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.

5.2Urinary Retention Urinary retention has been reported post-marketing with levocetirizine dihydrochloride. Levocetirizine dihydrochloride should be used with caution in patients with predisposing factors of urinary retention (e.g., spinal cord lesion, prostatic hyperplasia) as levocetirizine dihydrochloride may increase the risk of urinary retention. Discontinue levocetirizine dihydrochloride if urinary retention occurs.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Use of levocetirizine dihydrochloride has been associated with somnolence, fatigue, asthenia, and urinary retention [see Warnings and Precautions ( 5 ) ]. The most common adverse reactions (rate ≥2% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age. In subjects 1 to 5 years of age, the most common adverse reactions (rate ≥2% and > placebo) were pyrexia, diarrhea, vomiting, and otitis media.

In subjects 6 to 11 months of age, the most common adverse reactions (rate ≥3% and >placebo) were diarrhea and constipation. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience The safety data described below reflect exposure to levocetirizine dihydrochloride in 2708 patients with allergic rhinitis or chronic idiopathic urticaria in 14 controlled clinical trials of 1 week to 6 months duration. The short-term (exposure up to 6 weeks) safety data for adults and adolescents are based upon eight clinical trials in which 1896 patients (825 males and 1071 females aged 12 years and older) were treated with levocetirizine dihydrochloride 2.5, 5, or 10 mg once daily in the evening.

The short-term safety data from pediatric patients are based upon two clinical trials in which 243 children with allergic rhinitis (162 males and 81 females 6 to 12 years of age) were treated with levocetirizine dihydrochloride 5 mg once daily for 4 to 6 weeks, one clinical trial in which 114 children (65 males and 49 females 1 to 5 years of age) with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine dihydrochloride 1.25 mg twice daily for 2 weeks, and one clinical trial in which 45 children (28 males and 17 females 6 to 11 months of age) with symptoms of allergic rhinitis or chronic urticaria were treated with levocetirizine dihydrochloride 1.25 mg once daily for 2 weeks.

The long-term (exposure of 4 or 6 months) safety data in adults and adolescents are based upon two clinical trials in which 428 patients (190 males and 238 females) with allergic rhinitis were exposed to treatment with levocetirizine dihydrochloride 5 mg once daily. Long term safety data are also available from an 18-month trial in 255 levocetirizine dihydrochloride-treated subjects 12 to 24 months of age. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

Adults and A dolescents 12 years of Age and Older In studies up to 6 weeks in duration, the mean age of the adult and adolescent patients was 32 years, 44% of the patients were men and 56% were women, and the large majority (more than 90%) was Caucasian. In these trials 43% and 42% of the subjects in the levocetirizine dihydrochloride 2.5 mg and 5 mg groups, respectively, had at least one adverse event compared to 43% in the placebo group. In placebo-controlled trials of 1 to 6 weeks in duration, the most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis, and most were mild to moderate in intensity.

Somnolence with levocetirizine dihydrochloride showed dose ordering between tested doses of 2.5, 5 and 10 mg and was the most common adverse reaction leading to discontinuation (0.5%). Table 1 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 12 years and older exposed to levocetirizine dihydrochloride 2.5 mg or 5 mg in eight placebo-controlled clinical trials and that were more common with levocetirizine dihydrochloride than placebo. Table 1 Adverse Reactions Reported in ≥ 2%* of Subjects Aged 12 Years and Older Exposed to Levocetirizine Dihydrochloride 2.5 mg or 5 mg Once Daily i…

🔄 Drug Interactions 142 words ▾

7 DRUG INTERACTIONS In vitro data indicate that levocetirizine is unlikely to produce pharmacokinetic interactions through inhibition or induction of liver drug-metabolizing enzymes. No in vivo drug-drug interaction studies have been performed with levocetirizine. Drug interaction studies have been performed with racemic cetirizine.

7.1Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline, and Pseudoephedrine Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. There was a small decrease (~16%) in the clearance of cetirizine caused by a 400 mg dose of theophylline. It is possible that higher theophylline doses could have a greater effect.

7.2Ritonavir Ritonavir increased the plasma AUC of cetirizine by about 42% accompanied by an increase in half-life (53%) and a decrease in clearance (29%) of cetirizine. The disposition of ritonavir was not altered by concomitant cetirizine administration.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Renal Impairment Because levocetirizine dihydrochloride is substantially excreted by the kidneys, the risk of adverse reactions to this drug may be greater in patients with impaired renal function ( 8.6 and 12.3 ). Pediatric Use Do not exceed the recommended doses of 2.5 mg and 1.25 mg once daily in children 6 to 11 years of age .Systemic exposure with the se doses in respective pediatric age groups is comparable to that from a 5 mg once daily dose in adults. ( 12.3 ).

8.1Pregnancy Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine dihydrochloride should be used during pregnancy only if clearly needed. Teratogenic Effects In rats and rabbits, levocetirizine was not teratogenic at oral doses approximately 320 and 390, respectively, times the maximum recommended daily oral dose in adults on a mg/m 2 basis.

8.3Nursing Mothers No peri-and post-natal animal studies have been conducted with levocetirizine. In mice, cetirizine caused retarded pup weight gain during lactation at an oral dose in dams that was approximately 40 times The maximum recommended daily oral dose in adults on a mg/m 2 basis. Studies in beagle dogs indicated that approximately 3% of the dose of cetirizine was excreted in milk.

Cetirizine has been reported to be excreted in human breast milk. Because levocetirizine is also expected to be excreted in human milk, use of levocetirizine dihydrochloride in nursing mothers is not recommended.

8.4Pediatric Use The recommended dose of levocetirizine dihydrochloride for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older [see Clinical Studies ( 14 ) ]. The recommended dose of levocetirizine dihydrochloride in patients 6 months to 2 years of age for the treatment of the symptoms of perennial allergic rhinitis and 6 months to 11 years of age with chronic idiopathic urticaria is based on cross-study comparisons of the systemic exposure of levocetirizine dihydrochloride in adults and pediatric patients and on the safety profile of levocetirizine dihydrochloride in both adult and pediatric patients at doses equal to or higher than the recommended dose for patients 6 months to 11 years of age.

The safety of levocetirizine dihydrochloride 5 mg once daily was evaluated in 243 pediatric patients 6 to 12 years of age in two placebo-controlled clinical trials lasting 4 and 6 weeks. The safety of levocetirizine dihydrochloride 1.25 mg twice daily was evaluated in one 2-week clinical trial in 114 pediatric patients 1 to 5 years of age and the safety of levocetirizine dihydrochloride 1.25 mg once daily was evaluated in one 2-week clinical trial in 45 pediatric patients 6 to 11 months of age [see Adverse Reactions ( 6.1 ) ].

The effectiveness of levocetirizine dihydrochloride 1.25 mg once daily (6 months to 5 years of age) and 2.5 mg once daily (6 to 11 years of age) for the treatment of the symptoms of perennial allergic rhinitis and chronic idiopathic urticaria is supported by the extrapolation of demonstrated efficacy of levocetirizine dihydrochloride 5 mg once daily in patients 12 years of age and older based on the pharmacokinetic comparison between adults and children. Cross-study comparisons indicate that administration of a 5 mg dose of levocetirizine dihydrochloride to 6 to 12 year old pediatric patients resulted in about 2-fold the systemic exposure (AUC) observed when 5 mg of levocetirizine dihydrochloride was administered to healthy adults.

Therefore, in children 6 to 11 years of age the recommended dose of 2.5 mg once daily should not be exceeded. In a population pharmacokinetics study the administration of 1.25 mg once daily in children 6 months to 5 years of age resulted in systemic exposure comparable to 5 m…

🤰 Pregnancy 69 words ▾

8.1Pregnancy Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine dihydrochloride should be used during pregnancy only if clearly needed. Teratogenic Effects In rats and rabbits, levocetirizine was not teratogenic at oral doses approximately 320 and 390, respectively, times the maximum recommended daily oral dose in adults on a mg/m 2 basis.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The recommended dose of levocetirizine dihydrochloride for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older [see Clinical Studies ( 14 ) ]. The recommended dose of levocetirizine dihydrochloride in patients 6 months to 2 years of age for the treatment of the symptoms of perennial allergic rhinitis and 6 months to 11 years of age with chronic idiopathic urticaria is based on cross-study comparisons of the systemic exposure of levocetirizine dihydrochloride in adults and pediatric patients and on the safety profile of levocetirizine dihydrochloride in both adult and pediatric patients at doses equal to or higher than the recommended dose for patients 6 months to 11 years of age.

The safety of levocetirizine dihydrochloride 5 mg once daily was evaluated in 243 pediatric patients 6 to 12 years of age in two placebo-controlled clinical trials lasting 4 and 6 weeks. The safety of levocetirizine dihydrochloride 1.25 mg twice daily was evaluated in one 2-week clinical trial in 114 pediatric patients 1 to 5 years of age and the safety of levocetirizine dihydrochloride 1.25 mg once daily was evaluated in one 2-week clinical trial in 45 pediatric patients 6 to 11 months of age [see Adverse Reactions ( 6.1 ) ].

The effectiveness of levocetirizine dihydrochloride 1.25 mg once daily (6 months to 5 years of age) and 2.5 mg once daily (6 to 11 years of age) for the treatment of the symptoms of perennial allergic rhinitis and chronic idiopathic urticaria is supported by the extrapolation of demonstrated efficacy of levocetirizine dihydrochloride 5 mg once daily in patients 12 years of age and older based on the pharmacokinetic comparison between adults and children. Cross-study comparisons indicate that administration of a 5 mg dose of levocetirizine dihydrochloride to 6 to 12 year old pediatric patients resulted in about 2-fold the systemic exposure (AUC) observed when 5 mg of levocetirizine dihydrochloride was administered to healthy adults.

Therefore, in children 6 to 11 years of age the recommended dose of 2.5 mg once daily should not be exceeded. In a population pharmacokinetics study the administration of 1.25 mg once daily in children 6 months to 5 years of age resulted in systemic exposure comparable to 5 mg once daily in adults. [See Dosage and Administration ( 2.2 ); Clinical Studies ( 14 ); and Clinical Pharmacology ( 12.3 ) ].

🧓 Geriatric Use 90 words ▾

8.5Geriatric Us e Clinical studies of levocetirizine dihydrochloride for each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

🆘 Overdosage 196 words ▾

10 O VERDOSAGE Over dosage has been reported with levocetirizine dihydrochloride. Symptoms of overdose may include drowsiness in adults. In children agitation and restlessness may initially occur, followed by drowsiness.

There is no known specific antidote to levocetirizine dihydrochloride. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine dihydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.

The acute maximal non-lethal oral dose of levocetirizine was 240 mg/kg in mice (approximately 190 times the maximum recommended daily oral dose in adults, approximately 230 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 180 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m 2 basis). In rats the maximal non-lethal oral dose was 240 mg/kg (approximately 390 times the maximum recommended daily oral dose in adults, approximately 460 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 370 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m 2 basis).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanis m of Action Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H 1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. In vitro binding studies revealed that levocetirizine has an affinity for the human H 1 -receptor 2-fold higher than that of cetirizine (Ki = 3nmol/L vs.

6nmol/L, respectively). The clinical relevance of this finding is unknown.

12.2Pharmacodynamics Studies in adult healthy subjects showed that levocetirizine at doses of 2.5 mg and 5 mg inhibited the skin wheal and flare caused by the intradermal injection of histamine. In contrast, dextrocetirizine exhibited no clear change in the inhibition of the wheal and flare reaction. Levocetirizine at a dose of 5 mg inhibited the wheal and flare caused by intradermal injection of histamine in 14 pediatric subjects (aged 6 to 11 years) and the activity persisted for at least 24 hours.

The clinical relevance of histamine wheal skin testing is unknown. A QT/QTc study using a single dose of 30 mg of levocetirizine did not demonstrate an effect on the QTc interval. While a single dose of levocetirizine had no effect, the effects of levocetirizine may not be at steady state following single dose.

The effect of levocetirizine on the QTc interval following multiple dose administration is unknown. Levocetirizine is not expected to have QT/QTc effects because of the results of QTc studies with cetirizine and the long post-marketing history of cetirizine without reports of QT prolongation.

12.3Pharmacokinetics Levocetirizine exhibited linear pharmacokinetics over the therapeutic dose range in adult healthy subjects. Absorption Levocetirizine is rapidly and extensively absorbed following oral administration. In adults, peak plasma concentrations are achieved 0.9 hour after administration of the oral tablet.

The accumulation ratio following daily oral administration is 1.12 with steady state achieved after 2 days. Peak concentrations are typically 270 ng/mL and 308 ng/mL following a single and a repeated 5 mg once daily dose, respectively. Food had no effect on the extent of exposure (AUC) of the levocetirizine tablet, but T max was delayed by about 1.25 hours and C max was decreased by about 36% after administration with a high fat meal; therefore, levocetirizine can be administered with or without food.

A dose of 5 mg (10 mL) of levocetirizine dihydrochloride oral solution is bioequivalent to a 5 mg dose of levocetirizine dihydrochloride tablets. Following oral administration of a 5 mg dose of levocetirizine dihydrochloride oral solution to healthy adult subjects, the mean peak plasma concentrations were achieved approximately 0.5 hour post-dose. Distribution The mean plasma protein binding of levocetirizine in vitro ranged from 91 to 92%, independent of concentration in the range of 90 to 5000 ng/mL, which includes the therapeutic plasma levels observed.

Following oral dosing, the average apparent volume of distribution is approximately

0.4L/kg, representative of distribution in total body water. Metabolism The extent of metabolism of levocetirizine in humans is less than 14% of the dose and therefore differences resulting from genetic polymorphism or concomitant intake of hepatic drug metabolizing enzyme inhibitors are expected to be negligible. Metabolic pathways include aromatic oxidation, N- and O-dealkylation, and taurine conjugation.

Dealkylation pathways are primarily mediated by CYP 3A4 while aromatic oxidation involves multiple and/or unidentified CYP isoforms. Elimination The plasma half-life in adult healthy subjects was about 8 to 9 hours after administration of oral tablets and oral solution, and the mean oral total body clearance for levocetirizine was approximately 0.63 mL/kg/min. The major route of excretion of levocetirizine and its metabolites is via urine, accounting fo…

🧬 Mechanism of Action 78 words ▾

12.1Mechanis m of Action Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H 1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. In vitro binding studies revealed that levocetirizine has an affinity for the human H 1 -receptor 2-fold higher than that of cetirizine (Ki = 3nmol/L vs.

6nmol/L, respectively). The clinical relevance of this finding is unknown.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Levocetirizine dihydrochloride tablets, USP are white to off white, oval shaped biconvex, film-coated tablet debossed with 'I' and '12' on one side and score line on the other side and contain 5 mg levocetirizine dihydrochloride. They are supplied in Bottles of 30’s tablets Bottles of 90's tablets NDC 10135-0639-30 NDC 10135-0639-90 Storage: Store at 20 to 25ºC (68 to 77ºF); excursions permitted to 15 to 30ºC (59 to 86°F) [see USP Controlled Room Temperature].

📋 Description 208 words ▾

11 DESCRIPTION Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets USP, is an orally active H 1 -receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the Renantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties.

The molecular formula of levocetirizine dihydrochloride is C 21 H 25 ClN 2 O 3 •2HCl. The molecular weight is 461.82 and the chemical structure is shown below: Levocetirizine dihydrochloride is a white to off white crystalline powder and is water soluble. Levocetirizine dihydrochloride tablets USP 5 mg are formulated as immediate release, white to off white, oval shaped biconvex, film-coated tablet for oral administration.

The tablets are debossed with 'I' and '12' on one side and score line on the other side. Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.

The chemical structure for Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets USP, is an orally active H 1-receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties.

The molecular formula of levocetirizine dihydrochloride is C 21H 25ClN 2O 3•2HCl.

💬 Information for Patients 157 words ▾

17 PATIENT COUNSELING INFORMATION Somnolence Caution patients against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride. Concomitant Use of Alcohol and other Central Nervous System Depressants Instruct patients to avoid concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants because additional reduction in mental alertness may occur.

Dosing of Levocetirizine Dihydrochloride Tablets, USP Do not exceed the recommended daily dose in adults and adolescents 12 years of age and older of 5 mg once daily in the evening. In children 6 to 11 years of age the recommended dose is 2.5 mg once daily in the evening. Advise patients to not ingest more than the recommended dose of levocetirizine dihydrochloride because of the increased risk of somnolence at higher doses.

Manufactured for & Distributed By: Marlex Pharmaceuticals, Inc . New Castle, DE 19720 Revis ed: 1/18ML

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10135-0541-01 · Marlex 10135-0666-01 · Marlex →
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