Children's Loratadine Oral Solution USP, 5mg/5 mL

Manufacturer: Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date: 2026-04-08
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:53:02

Label at a glance#

ProductChildrens Loratadine

Active ingredientLORATADINE

Label structure11 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

use only with enclosed dosing cup mL=milliliter adults and children 6 years and over 10 mL daily; do not take more than 10 mL in 24 hours children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing. see bottom panel for lot number and expiration date store between 20° and 25°C (68° and 77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-866-923-4914

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 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

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

use only with enclosed dosing cup
mL=milliliter

adults and children 6 years and over	10 mL daily; do not take more than 10 mL in 24 hours
children 2 to under 6 years of age	5 mL daily; do not take more than 5 mL in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

STORAGE AND HANDLING SECTION

do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
see bottom panel for lot number and expiration date
store between 20° and 25°C (68° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

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

Made In Israel

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-2073-8

Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL

Carton

Principal Display Panel - 120 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	7
692783	loratadine 1 MG/ML Oral Solution	SCD	7
692783	loratadine 5 MG per 5 ML Oral Solution	SY	7

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0351672207380	GTIN-13: 0351672207380 EAN-13: 0351672207380 GTIN-12: 351672207380 UPC-A: 351672207380 GTIN storage (14 digits): 00351672207380	Loratadine 4oz Fruit Flavor Carton.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-2073-4	Childrens Loratadine	60 mL in 1 BOTTLE	SOLUTION	60	7
51672-2073-4	Childrens Loratadine	1 in 1 CARTON	SOLUTION	1	7
51672-2073-5	Childrens Loratadine	180 mL in 1 BOTTLE	SOLUTION	180	7
51672-2073-5	Childrens Loratadine	1 in 1 CARTON	SOLUTION	1	7
51672-2073-8	Childrens Loratadine	120 mL in 1 BOTTLE	SOLUTION	120	7
51672-2073-8	Childrens Loratadine	1 in 1 CARTON	SOLUTION	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2073-8	ML - Milliliter	51672-2073	8d48a532-2118-4d9a-bd23-7f5e5e5d50d1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	2
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	2
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	2
sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	2
sucrose	INACTIVE INGREDIENT	C151H8M554	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Childrens Loratadine
Loratadine
CITRIC ACID MONOHYDRATE
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM METABISULFITE
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51672-2073	51672-2073-8, 51672-2073-4, 51672-2073-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
SUCROSE	C151H8M554	IACT
LORATADINE	7AJO3BO7QN	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
sodium metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / ORAL	640 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL	32400 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL	22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL	22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL	70000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / ORAL	640 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL	446 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL	660 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL	70000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL	446 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL	32400 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL	446 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL	32400 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL	70000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL	660 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL	22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / ORAL	640 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL	660 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL	446 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL	70000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL	32400 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL	660 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium metabisulfite	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / ORAL	640 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL	22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates

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
A076805-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2004-08-20

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	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`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
Childrens Loratadine	LORATADINE	Sun Pharmaceutical Industries, Inc.	78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0	2026-04-08	Warnings	Exact identifier ndc (package): 51672-2073-8 ndc (package): 51672-2073-4 ndc (package): 51672-2073-5 ndc (product): 51672-2073 ndc11 (package): 51672207308 ndc11 (package): 51672207304 ndc11 (package): 51672207305 spl id: 4ef454c5-7e60-4107-e063-6394a90a6f93 spl set id: 78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0

Reported adverse events (FAERS/openFDA)#

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