Loratadine Oral Solution USP, 5mg/5 mL (OTC)

Manufacturer: Camber Consumer Care Inc | Hetero Labs Limited Unit III | Annora Pharma Private Limited
Effective date: 2026-04-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:53:20

Label at a glance#

ProductLoratadine

Active ingredientLORATADINE

Label structure14 sections

Dosage and administration

•use only with enclosed dosing cup adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Contacts and useful links#

PhoneLabel contact1-888-588-1418

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)
Loratadine USP, 5mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

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

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

•use only with enclosed dosing cup

adults and children 6 years and over	2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age	1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• Sodium Free
• Do not use if carton is opened, or if bottle wrap printed with “SEALED FOR SAFETY” is broken or missing.
• store between 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ART grape flavor, edetate disodium dihydrate, glycerin, maltitol solution, monobasic sodium phosphate, non crystallizing sorbitol solution, phosphoric acid, propylene glycol, purified water, sodium benzoate and sucralose

QUESTIONS OR COMMENTS?

SPL UNCLASSIFIED SECTION

Call 1-888-588-1418

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine Oral Solution USP, 5 mg/5mL 120 mL Carton Label-Hetero

loratadineOShetero

Loratadine Oral Solution USP, 5 mg/5mL 120 mL Carton Label-Annora

loratadineOSannora

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	2
692783	loratadine 1 MG/ML Oral Solution	SCD	2
692783	loratadine 5 MG per 5 ML Oral Solution	SY	2

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0369230322123	GTIN-13: 0369230322123 EAN-13: 0369230322123 GTIN-12: 369230322123 UPC-A: 369230322123 GTIN storage (14 digits): 00369230322123	loratadineoshetero.jpg, loratadineosannora.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69230-322-12	Loratadine	1 in 1 CARTON	SOLUTION	1	2
69230-322-12	Loratadine	120 mL in 1 BOTTLE	SOLUTION	120	2
69230-322-24	Loratadine	240 mL in 1 BOTTLE	SOLUTION	240	2
69230-322-24	Loratadine	1 in 1 CARTON	SOLUTION	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69230-322-12	ML - Milliliter	69230-322	59566099-159a-4c72-9444-88d5eba3b2b9	1	2021-11-09
69230-322-24	ML - Milliliter	69230-322	5cc969d4-5d89-4fc0-ae5e-55c3a6f3db4d	1	2021-11-09

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Loratadine
EDETATE DISODIUM
GLYCERIN
MALTITOL
SODIUM PHOSPHATE, MONOBASIC
SORBITOL
PHOSPHORIC ACID
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69230-322	69230-322-12, 69230-322-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
MALTITOL	D65DG142WK	IACT
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	IACT
SORBITOL	506T60A25R	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	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 44.

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
A210409-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2021-05-07

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
2026-10-15 13:18:30	2026-09	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210409-001	LORATADINE	1MG/ML	SYRUP / ORAL	2021-05-07	`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
Loratadine	LORATADINE	Camber Consumer Care Inc	4dec6d48-78e0-48a4-9274-25f6cbf26a2c	2026-04-10	Warnings	Exact identifier ndc (package): 69230-322-12 ndc (package): 69230-322-24 ndc (product): 69230-322 ndc11 (package): 69230032224 ndc11 (package): 69230032212 spl id: 4f169a54-c021-23db-e063-6294a90a422e spl set id: 4dec6d48-78e0-48a4-9274-25f6cbf26a2c

Reported adverse events (FAERS/openFDA)#

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