Dye-Free Loratadine Chewable Tablets USP, 10 mg

Manufacturer: Ohm Laboratories Inc.
Effective date: 2026-05-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:58:05

Label at a glance#

ProductDYE-FREE LORATADINE

Active ingredientLORATADINE

Label structure11 sections

Indications and uses

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

Dosage and administration

chew or crush tablets completely before swallowing. adults and children 6 years and over chew 1 tablets daily; not more than 1 chewable tablets in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25°C (68° to 77°F).

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-406-7984

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable 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
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).

Directions

DOSAGE & ADMINISTRATION SECTION

chew or crush tablets completely before swallowing.

adults and children 6 years and over	chew 1 tablets daily; not more than 1 chewable tablets 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

phenylketonurics: contains phenylalanine 1.25 mg per tablet.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° to 25°C (68° to 77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

OTC - QUESTIONS SECTION

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Keep the carton. It contains important information. See end panel for expiration date.

SPL UNCLASSIFIED SECTION

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

0625

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2265266	loratadine 10 MG Chewable Tablet	PSN	2
2265266	loratadine 10 MG Chewable Tablet	SCD	2

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0351660755022	GTIN-13: 0351660755022 EAN-13: 0351660755022 GTIN-12: 351660755022 UPC-A: 351660755022 GTIN storage (14 digits): 00351660755022	Ohm Lora Chew Tab Grape 10mg 24ct Blister Carton.jpg
Data code	ITF	05258390		Ohm Lora Chew Tab Grape 10mg 24ct Blister Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51660-755-02	DYE-FREE LORATADINE	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	2
51660-755-02	DYE-FREE LORATADINE	3 in 1 CARTON	TABLET, CHEWABLE	3	2
51660-755-03	DYE-FREE LORATADINE	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	2
51660-755-03	DYE-FREE LORATADINE	6 in 1 CARTON	TABLET, CHEWABLE	6	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51660-755-02	EA - Each	51660-755	b193283a-6934-4fb8-9ee2-a06688418c70	1	2026-05-22
51660-755-03	EA - Each	51660-755	69c9fecf-5589-449f-a6d0-19c28d9cda6c	1	2026-05-22

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

DYE-FREE LORATADINE
LORATADINE
ASPARTAME
ANHYDROUS CITRIC ACID
SILICON DIOXIDE
MAGNESIUM STEARATE
MANNITOL
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51660-755	51660-755-02, 51660-755-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASPARTAME	Z0H242BBR1	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT
LORATADINE	7AJO3BO7QN	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2026-01-15	monthly-update	2026-06-03 17:52:56

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210088-001	LORATADINE	LORATADINE	5MG	TABLET, CHEWABLE / ORAL			2018-04-16
A210088-002	LORATADINE	LORATADINE	10MG	TABLET, CHEWABLE / ORAL			2025-04-25

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 · 49 observed 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	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210088-002	LORATADINE	10MG	TABLET, CHEWABLE / ORAL	2025-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210088-002	LORATADINE	10MG	TABLET, CHEWABLE / ORAL	2025-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210088-002	LORATADINE	10MG	TABLET, CHEWABLE / ORAL	2025-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210088-002	LORATADINE	10MG	TABLET, CHEWABLE / ORAL	2025-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210088-002	LORATADINE	10MG	TABLET, CHEWABLE / ORAL	2025-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`a67488948f0b…`

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
DYE-FREE LORATADINE	LORATADINE	Ohm Laboratories Inc.	48744daa-7079-283d-e063-6394a90a2c9a	2026-05-05	Warnings	Exact identifier ndc (package): 51660-755-03 ndc (package): 51660-755-02 ndc (product): 51660-755 ndc11 (package): 51660075503 ndc11 (package): 51660075502 spl id: 51156462-921d-facf-e063-6294a90a89fe spl set id: 48744daa-7079-283d-e063-6394a90a2c9a

Reported adverse events (FAERS/openFDA)#

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