Loratadine Tablets USP 10 mg

Manufacturer
CVS Pharmacy, Inc. | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2026-03-20
Label type
Human OTC Drug Label
Version
9
Source
full-release
Hydrated at
2026-06-01 01:51:09

Label at a glance#

ProductLoratadine
Active ingredientLORATADINE
Label structure16 sections

Indications and uses

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

Dosage and administration

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken store at 20° to 25°C (68° to 77°F) protect from excessive moisture

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine USP 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


  • runny nose                                                                    
  • itchy, watery eyes
  • sneezing 
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over
1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Other information

STORAGE AND HANDLING SECTION


  • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?

OTC - QUESTIONS SECTION


call 1-855-274-4122

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive,
Woonsocket, RI 02895
©2023 CVS/pharmacy
CVS.com®
1-800-SHOP CVS

Made in India            V-31735
100 % money back guaranteed.
CVS.com/returnpolicy

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (90 Tablets Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVS
Health®
NDC69842-242-19
Indoor & Outdoor Allergies
Non-Drowsy*
Allergy Relief
LORATADINE TABLETS U
SP 10 mg
Antihistamine
24 Hours Relief of:
Sneezing; Runny nose;
Itchy, watery eyes;
Itchy throat or nose

 *When taken as directed.
See Drug Facts Panel.            
90 TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (90 Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVS
Health®
Compare to the active
ingredient in Claritin® Tablets†
Indoor & Outdoor Allergies
NDC 69842-242-19
Non-Drowsy*
Allergy Relief
LORATADINE TABLETS
USP 10 mg
Antihistamine
24 Hour

Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose


Actual Bottle Size
on Side Panel

 *When taken as directed.
See Drug Facts Panel.     
Actual Size       
90 TABLETS             Actual Bottle Size
                                    on Side Panel 
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (20 Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVS™                                   NDC 69842-242-67
24
HR RELIEF

 actual size

Non-Drowsy†

ALLERGY RELIEF

Loratadine Tablets USP, 10 mg
Antihistamine

Compare to Claritin®  active ingredient *
24-Hour Relief of:
 Runny nose, Itchy throat or nose, Sneezing & Itchy, watery eyes

†When taken as directed. See Drug Facts Panel.  
Indoor
& Outdoor
Allergies

20
TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN9
311372loratadine 10 MG Oral TabletSCD9
311372loratadine 10 MG 24 HR Oral TabletSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428056011GTIN-13: 0050428056011
EAN-13: 0050428056011
GTIN-12: 050428056011
UPC-A: 050428056011
GTIN storage (14 digits): 00050428056011
loratadine-fig3.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-242-09Loratadine10 in 1 BLISTER PACKTABLET109
69842-242-09Loratadine3 in 1 CARTONTABLET39
69842-242-17Loratadine45 in 1 BOTTLETABLET459
69842-242-17Loratadine1 in 1 CARTONTABLET19
69842-242-19Loratadine1 in 1 CARTONTABLET19
69842-242-19Loratadine90 in 1 BOTTLETABLET909
69842-242-39Loratadine365 in 1 BOTTLETABLET3659
69842-242-45Loratadine2 in 1 CARTONTABLET29
69842-242-45Loratadine120 in 1 BOTTLETABLET1209
69842-242-54Loratadine1 in 1 CARTONTABLET19
69842-242-54Loratadine70 in 1 BOTTLETABLET709
69842-242-60Loratadine1 in 1 CARTONTABLET19
69842-242-60Loratadine5 in 1 BLISTER PACKTABLET59
69842-242-67Loratadine10 in 1 BLISTER PACKTABLET109
69842-242-67Loratadine2 in 1 CARTONTABLET29
69842-242-83Loratadine1 in 1 CARTONTABLET19
69842-242-83Loratadine10 in 1 BLISTER PACKTABLET109
69842-242-91Loratadine3 in 1 CARTONTABLET39
69842-242-91Loratadine10 in 1 BLISTER PACKTABLET109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-242-39EA - Each69842-24232246d33-ff47-485c-86b5-a158cc91330d12021-03-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208314-001LORATADINELORATADINE10MGTABLET / ORAL2018-04-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINECVS Pharmacy, Inc.3937f769-e8e2-4b32-8338-21b0a74a86972026-03-20WarningsExact identifier
ndc (package): 69842-242-39
ndc (package): 69842-242-17
ndc (package): 69842-242-67
ndc (package): 69842-242-09
ndc (package): 69842-242-91
ndc (package): 69842-242-45
ndc (package): 69842-242-60
ndc (package): 69842-242-83
ndc (package): 69842-242-54
ndc (package): 69842-242-19
ndc (product): 69842-242
ndc11 (package): 69842024217
ndc11 (package): 69842024260
ndc11 (package): 69842024209
ndc11 (package): 69842024219
ndc11 (package): 69842024283
ndc11 (package): 69842024291
ndc11 (package): 69842024245
ndc11 (package): 69842024254
ndc11 (package): 69842024267
ndc11 (package): 69842024239
spl id: 434285f9-116c-458e-a598-fcdcd7be2825
spl set id: 3937f769-e8e2-4b32-8338-21b0a74a8697

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.