Allergy Relief levocetirizine dihydrochloride 5 mg Tablet, Coated, 35-count — NDC 46122-0531-05 package photo

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

by AMERISOURCEBERGEN DRUG CORPORATION · 1 BOTTLE in 1 CARTON (46122-531-05) / 35 TABLET, COATED in 1 BOTTLE
NDC 46122-0531-05
🏷️ FDA NDC (as labeled) 46122-531-05 billing pads the product segment with a zero
This package
Contains35-count Cost per ea$0.2204 NADAC Per package$7.71 / 35 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.4159/unit — full pricing hub ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 46122-531-05
Product NDC 46122-531
11-digit billing NDC 46122053105
NCPDP billing unit EA — each (per item)
RxCUI 855172
UNII SOD6A38AGA
Application # ANDA210375
SPL Set ID fdf54de3-16a9-3b28-b4c4-d745322b3d3c
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 2018-04-20
Route ORAL
Dosage form TABLET, COATED
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
GPI-14 41550027100320
GPI class GNP Allergy Relief 24 HR
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 GNP ALLERGY RELIEF 5 MG TABLET
FDB brand name Allergy Relief
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 46122-531-05 — 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 → 46122-0531-05. 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) 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

LabelerAMERISOURCEBERGEN DRUG CORPORATION
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA210375 (ANDA)
Labeler code46122
First marketedApr 2018
Product typeHuman Otc Drug
Portfolio37 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 GNP ALLERGY RELIEF 5 MG TABLET Ingredient Levocetirizine Dihydrochloride
📗 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
ImprintL
Size9 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.220 $7.71 / 35 tablets
Medicaid paysCMS SDUD · 12 mo $0.4159 $14.56 / 35 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.223 $0.142
▲ Up 15% over the last 24 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
Levocetirizine Dihydrochloride 5 mg 00093-7701-98 Teva 90 tablets $0.052 AB Availability likely save 77%
Levocetirizine Dihydrochloride 5 mg 68462-0346-90 Glenmark 90 tablets $0.052 AB Availability likely save 77%
Levocetirizine Dihydrochloride 5 mg 69367-0238-09 Westminster 90 tablets $0.052 AB Availability likely save 77%
Allergy Relief 5 mgthis 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 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
Apr 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.

🗺️ 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 46122-0531-05, 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 – Q1 2026 · 5 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
308
Units reimbursed last 4 qtrs
10K
Gross reimbursed last 4 qtrs
$4.2K
Avg / prescription
$13.56
Avg / unit
$0.4159
Latest quarter Q1 2026
23Rx
Medicaid pays / ea
$0.4159
gross reimbursed
vs
NADAC / ea
$0.2204
acquisition cost
=
Spread
+$0.1955
+89% vs cost
What Medicaid paid per ea (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
63% FFS 37% MCO
Fee-for-service · 193 Rx Managed care · 115 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: 1,145 units · 11.4 per 100k residents MI New York: no data reported 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: 1,590 units · 17.1 per 100k residents NJ Massachusetts: no data reported MA California: 7,095 units · 18.2 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: 208 units · 4.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported 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: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported 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
4.618.2
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 California 18.2 /100k
2 New Jersey 17.1 /100k
3 Michigan 11.4 /100k
4 Kentucky 4.6 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
80 tablets46122-0531-61 323 Rx · $6,419
5 tablets46122-0531-52 No Medicaid data
Drug total (last 4 qtrs): 631 Rx · 22,553 units · $10,594 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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 Per unit Per pack Marketing startStatus
46122-0531-05 You're viewing this 1 BOTTLE in 1 CARTON (46122-531-05) / 35 TABLET, COATED in 1 BOTTLE $0.2204 / ea $7.71 2018-04-20 Active
46122-0531-52 2 BLISTER PACK in 1 CARTON (46122-531-52) / 5 TABLET, COATED in 1 BLISTER PACK $0.2204 / ea $2.20 2018-07-06 Discontinued by firm
46122-0531-61 1 BOTTLE in 1 CARTON (46122-531-61) / 80 TABLET, COATED in 1 BOTTLE $0.2204 / ea $17.63 2023-09-01 Active

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.2204 NADAC).

This pack accounts for about 49% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 46122-0531-05?
NDC 46122-0531-05 is a 35-count package — 1 bottle in 1 carton / 35 tablet, coated in 1 bottle.
What is the difference between NDC 46122-0531-05 and NDC 46122-0531-61?
Both are Allergy Relief levocetirizine dihydrochloride 5 mg Tablet, Coated — the drug itself is identical. NDC 46122-0531-05 is the 35-count package, while NDC 46122-0531-61 is the 80 tablets package.
What NDC number is used to bill for this package of Allergy Relief levocetirizine dihydrochloride 5 mg Tablet, Coated?
Bill NDC 46122-0531-05 — the 11-digit billing format is 46122053105. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 25 words

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

⏱️ Dosage and Administration 99 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 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours children under 6 years of age do not use consumers with kidney disease do not use

⚠️ Warnings 138 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 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 10 words

Active ingredient (in each tablet) Levocetirizine dihydrochloride USP, 5 mg

🧪 Inactive Ingredients 16 words

Inactive ingredients colloidal silicon dioxide, 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 ↗
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.