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Allergy Relief levocetirizine dihydrochloride 5 mg Tablet, Film Coated, 35-count — NDC 41250-0488-01 package photo

Allergy Relief levocetirizine dihydrochloride 5 mg Tablet, Film Coated, 35-count

by Meijer Distribution Inc · 1 BOTTLE in 1 CARTON (41250-488-01) / 35 TABLET, FILM COATED in 1 BOTTLE
NDC 41250-0488-01
🏷️ FDA NDC (as labeled) 41250-488-01 billing pads the product segment with a zero
This package
Contains35-count Pack sizes2 compare ↓
Also comes in: 80 tablets 41250-0488-27
OTC 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) 41250-488-01
Product NDC 41250-488
11-digit billing NDC 41250048801
RxCUI 855172
UNII SOD6A38AGA
Application # ANDA211983
SPL Set ID ca6d0ba0-96af-41e9-a3e9-0c7783db3011
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 2020-02-06
Route ORAL
Dosage form TABLET, FILM COATED
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
Why two NDCs? The FDA registers this code as 41250-488-01 — 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 → 41250-0488-01. 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

LabelerMeijer Distribution Inc
Application holderPERRIGO R AND D CO
FDA applicationANDA211983 (ANDA)
Labeler code41250
First marketedFeb 2020
Product typeHuman Otc Drug
Portfolio244 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

📖 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
ImprintL9CZ;5
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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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.

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

The official label also stateshypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 80 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 mg 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 mgthis 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

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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 (matched by generic name) — 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.

🔬 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 ALLERGY RELIEF (this brand).

Top reported reactions

Fatigue19,798
Pain16,932
Headache14,344
Nausea13,604
Rash13,091
Dyspnoea12,903
Diarrhoea11,506

Reporter sex

181,432 reports

Serious outcomes

Death18,453
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 18,323 9,030
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
41250-0488-01 You're viewing this 1 BOTTLE in 1 CARTON (41250-488-01) / 35 TABLET, FILM COATED in 1 BOTTLE 2020-02-08 Active
41250-0488-27 1 BOTTLE in 1 CARTON (41250-488-27) / 80 TABLET, FILM COATED in 1 BOTTLE 2020-02-06 Active

Pack size FAQ

What quantity is in NDC 41250-0488-01?
NDC 41250-0488-01 is a 35-count package — 1 bottle in 1 carton / 35 tablet, film coated in 1 bottle.
What is the difference between NDC 41250-0488-01 and NDC 41250-0488-27?
Both are Allergy Relief levocetirizine dihydrochloride 5 mg Tablet, Film Coated — the drug itself is identical. NDC 41250-0488-01 is the 35-count package, while NDC 41250-0488-27 is the 80 tablets package.
What NDC number is used to bill for this package of Allergy Relief levocetirizine dihydrochloride 5 mg Tablet, Film Coated?
Bill NDC 41250-0488-01 — the 11-digit billing format is 41250048801. 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

Over-the-counter (OTC) 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 41250-488-01, 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: 41250-0488-01, written without dashes as 41250048801. 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 41250-0488-01, the first segment (41250) is the labeler code FDA assigned to Meijer Distribution Inc; the middle segment (0488) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Meijer Distribution 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 80 tablets (41250-0488-27). 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?
Meijer Distribution 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

⏱️ Dosage and Administration 107 words ▾

Directions adults 65 years of age and older • ask a doctor adults and children 12-64 years of age • take 1 tablet (5 mg) once daily in the evening • do not take more than 1 tablet (5 mg) in 24 hours • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age • take ½ tablet (2.5 mg) once daily in the evening • do not take more than ½ tablet (2.5 mg) in 24 hours children under 6 years of age • do not use consumers with kidney disease • do not use

⚠️ Warnings 150 words ▾

Warnings Do not use • if you have kidney disease • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have • ever had trouble urinating or emptying your bladder When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • you have trouble urinating or emptying your bladder • an allergic reaction to this product occurs.

Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Levocetirizine dihydrochloride 5 mg

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 41250-0484-62 · Meijer 41250-0493-65 · Meijer →
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.