LORATADINE

Manufacturer: Bionpharma Inc. | Patheon Softgels Inc.
Effective date: 2019-01-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:58:40

Label at a glance#

ProductLORATADINE

Active ingredientLORATADINE

Label structure9 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 capsule daily; not more than 1 capsule 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. (For Bottle Labels and Cartons) Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton) store between 20° to 25°C (68° to 77°F) protect from freezing

Contacts and useful links#

PhoneLabel contact1-888-235-2466

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over	1 capsule daily; not more than 1 capsule 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. (For Bottle Labels and Cartons)
Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton)
store between 20° to 25°C (68° to 77°F)
protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-235-2466

SPL UNCLASSIFIED SECTION

**This product in not manufactured or distributed by Bayer, owner of the registered trademark Claritin^® and Catalent Pharma Solutions, Inc, owner of the registered trademark LIQUI-GELS^®.

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Rev # 07/17

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69452-211-03

Compare to the active ingredient in Claritin^® Liqui-Gels^®**

Original Prescription Strenght

Non-Drowsy*

Loratadine Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

5 LIQUID-FILLED CAPSULES

*When taken as directed. See Drug Facts Panel

Do not use if carton is open, or if foil inner seal on bottle is broken

5's Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
828269	loratadine 10 MG 24HR Oral Capsule	PSN	2
828269	loratadine 10 MG Oral Capsule	SCD	2
828269	loratadine 10 MG 24HR Oral Capsule	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69452-211-03	LORATADINE	5 in 1 BOTTLE	CAPSULE, LIQUID FILLED	5	2
69452-211-03	LORATADINE	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	2
69452-211-07	LORATADINE	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	2
69452-211-07	LORATADINE	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	2
69452-211-16	LORATADINE	50 in 1 BOTTLE	CAPSULE, LIQUID FILLED	50	2
69452-211-16	LORATADINE	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	2
69452-211-26	LORATADINE	200 in 1 BOTTLE	CAPSULE, LIQUID FILLED	200	2
69452-211-26	LORATADINE	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-211	LORATADINE CAPSULE, LIQUID FILLED [BIONPHARMA INC.]	2	Current NDC, Legacy NDC, 8 package rows	20190301_59bebce3-2b82-4521-a796-2d4c83bcf669.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

LORATADINE
FD&C BLUE NO. 1
GELATIN
GLYCERIN
HYPROMELLOSES
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)
ISOPROPYL ALCOHOL
MANNITOL
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69452-211	69452-211-03, 69452-211-16, 69452-211-26, 69452-211-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LORATADINE	7AJO3BO7QN	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)	5WE8P977RQ	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MANNITOL	3OWL53L36A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

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
A202538-001	LORATADINE	LORATADINE	10MG	CAPSULE / ORAL			2018-12-21

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`f41ea6bd6efb…`

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
LORATADINE	LORATADINE	Bionpharma Inc.	59bebce3-2b82-4521-a796-2d4c83bcf669	2019-01-08	Warnings	Exact identifier ndc (package): 69452-211-26 ndc (package): 69452-211-03 ndc (package): 69452-211-07 ndc (package): 69452-211-16 ndc (product): 69452-211 ndc11 (package): 69452021116 ndc11 (package): 69452021103 ndc11 (package): 69452021107 ndc11 (package): 69452021126 spl id: 932678d1-e6bf-4154-ac00-b6b9c9fbd16e spl set id: 59bebce3-2b82-4521-a796-2d4c83bcf669

Reported adverse events (FAERS/openFDA)#

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