Loratadine 10mg

Manufacturer: Allegiant Health
Effective date: 2020-06-16
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 01:43:22

Label at a glance#

ProductAllergy Relief

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 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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10mg

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

OTC - STOP USE SECTION

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

Pregnancy/Breastfeeding

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 accidental overdose, contact a doctor or 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

SPL UNCLASSIFIED SECTION

store between 20° to 25°C (68° to 77°F)
protect from excessive moisture
do not use if imprinted seal under safety cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

*corn starch, lactose monohydrate, magnesium stearate ,
pregelantinized starch, *sodium starch glycolate

*May contain these ingredients

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine 10mgLoratadine 10mg

DailyMed RxNorm Mappings#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0369168414174	GTIN-13: 0369168414174 EAN-13: 0369168414174 GTIN-12: 369168414174 UPC-A: 369168414174 GTIN storage (14 digits): 00369168414174	414-475---health-a2z-loratadine-10mg-2.jpg
Data code	Code 128	X003Z68PNL		414-475---health-a2z-loratadine-10mg-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-414-02	Allergy Relief	150 in 1 BOTTLE	TABLET	150	10
69168-414-03	Allergy Relief	3 in 1 CARTON	TABLET	3	10
69168-414-03	Allergy Relief	10 in 1 BLISTER PACK	TABLET	10	10
69168-414-08	Allergy Relief	5 in 1 BLISTER PACK	TABLET	5	10
69168-414-09	Allergy Relief	10 in 1 BLISTER PACK	TABLET	10	10
69168-414-17	Allergy Relief	300 in 1 BOTTLE	TABLET	300	10
69168-414-30	Allergy Relief	30 in 1 BOTTLE	TABLET	30	10
69168-414-60	Allergy Relief	60 in 1 BOTTLE	TABLET	60	10
69168-414-99	Allergy Relief	365 in 1 BOTTLE	TABLET	365	10
69168-475-02	Loratadine 10mg	150 in 1 BOTTLE	TABLET	150	10
69168-475-05	Loratadine 10mg	500 in 1 BOTTLE	TABLET	500	10
69168-475-08	Loratadine 10mg	1 in 1 CARTON	TABLET	1	10
69168-475-08	Loratadine 10mg	5 in 1 BLISTER PACK	TABLET	5	10
69168-475-09	Loratadine 10mg	1 in 1 CARTON	TABLET	1	10
69168-475-09	Loratadine 10mg	10 in 1 BLISTER PACK	TABLET	10	10
69168-475-17	Loratadine 10mg	300 in 1 BOTTLE	TABLET	300	10
69168-475-30	Loratadine 10mg	1 in 1 CARTON	TABLET	1	10
69168-475-30	Loratadine 10mg	30 in 1 BOTTLE	TABLET	30	10
69168-475-60	Loratadine 10mg	60 in 1 BOTTLE	TABLET	60	10
69168-475-99	Loratadine 10mg	365 in 1 BOTTLE	TABLET	365	10

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Allergy Relief
Loratadine
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A
Loratadine 10mg

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69168-414	69168-414-17, 69168-414-03, 69168-414-60, 69168-414-30, 69168-414-09, 69168-414-08, 69168-414-02, 69168-414-99
69168-475	69168-475-02, 69168-475-08, 69168-475-09, 69168-475-17, 69168-475-99, 69168-475-60, 69168-475-30, 69168-475-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LORATADINE	7AJO3BO7QN	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	CNTM
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	CNTM
LORATADINE	7AJO3BO7QN	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	CNTM
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	CNTM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
9	2020-06-16	full-release	2026-06-01 01:15:22

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 · 2 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
A210722-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2019-12-23

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	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a50c72e98297…`

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
A211718-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2023-07-28

Observed Orange Book product history#

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	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211718-001	LORATADINE	10MG	TABLET / ORAL	2023-07-28	`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
Allergy Relief	LORATADINE	Allegiant Health	f0db3a13-43e6-4243-9a3a-7808ddd005e1	2020-06-16	Warnings	Exact identifier ndc (package): 69168-414-99 ndc (package): 69168-475-05 ndc (package): 69168-475-17 ndc (package): 69168-475-99 ndc (package): 69168-475-60 ndc (package): 69168-414-03 ndc (package): 69168-414-09 ndc (package): 69168-414-02 ndc (package): 69168-414-60 ndc (package): 69168-414-30 ndc (package): 69168-475-30 ndc (package): 69168-475-08 ndc (package): 69168-475-02 ndc (package): 69168-414-08 ndc (package): 69168-414-17 ndc (package): 69168-475-09 ndc (product): 69168-414 ndc (product): 69168-475 ndc11 (package): 69168041402 ndc11 (package): 69168041430 ndc11 (package): 69168047517 ndc11 (package): 69168047599 ndc11 (package): 69168047530 ndc11 (package): 69168047505 ndc11 (package): 69168047509 ndc11 (package): 69168047502 ndc11 (package): 69168041403 ndc11 (package): 69168041417 ndc11 (package): 69168047508 ndc11 (package): 69168041408 ndc11 (package): 69168047560 ndc11 (package): 69168041460 ndc11 (package): 69168041499 ndc11 (package): 69168041409 spl id: 1307fce8-d753-4df5-90f0-a902befdfe35 spl set id: f0db3a13-43e6-4243-9a3a-7808ddd005e1

Reported adverse events (FAERS/openFDA)#

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