CVS Loratadine

Manufacturer: CVS Pharmacy
Effective date: 2025-10-22
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:40:01

Label at a glance#

ProductCVS Loratadine

Active ingredientLORATADINE

Label structure8 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 of age 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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-908-242-6108

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 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

OTC - DO NOT USE SECTION

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 right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION


adults and children 6 years of age 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

SPL UNCLASSIFIED SECTION

safety sealed: do not use if printed safety seal under bottle cap is opened or torn
store between 20° and 25°C (68° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, lactose monohydrate, magnesium stearate, povidone

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311372	loratadine 10 MG 24HR Oral Tablet	PSN	3
311372	loratadine 10 MG Oral Tablet	SCD	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	3

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0050428000335	GTIN-13: 0050428000335 EAN-13: 0050428000335 GTIN-12: 050428000335 UPC-A: 050428000335 GTIN storage (14 digits): 00050428000335	Label - Bottle.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51316-184-10	CVS Loratadine	365 in 1 BOTTLE	TABLET	365		3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

CVS Loratadine
LORATADINE
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51316-184	51316-184-10

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
STARCH, CORN	O8232NY3SJ	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
LORATADINE	7AJO3BO7QN	ACTIB

Source Document#

Source XML

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214684-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2021-01-07

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Loratadine	LORATADINE	CVS Pharmacy	3d716988-da63-59e6-e063-6394a90a5b4b	2025-10-22	Warnings	Exact identifier ndc (package): 51316-184-10 ndc (product): 51316-184 ndc11 (package): 51316018410 spl id: 41c5ecce-51a2-733a-e063-6394a90a7327 spl set id: 3d716988-da63-59e6-e063-6394a90a5b4b

Reported adverse events (FAERS/openFDA)#

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