Label at a glance#

ProductLoratadine

Active ingredientLORATADINE

Label structure15 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

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

Storage and handling

each teaspoonful contains : sodium 6 mg do not use if carton is opened, or if cap safety seal is broken or missing. store at 20° to 25°C (68° to 77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-855-274-4122

PhoneLabel contact1-888-723-3929

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL teaspoonful)
Loratadine USP 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
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use 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 (1-800-222-1222) 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

STORAGE AND HANDLING SECTION

each teaspoonful contains: sodium 6 mg
do not use if carton is opened, or if cap safety seal is broken or missing.
store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-855-274-4122

DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99
PLEASANTON, CA 94566-0009
^‡1-888-723-3929

Made in India

Code:TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 21130-042-24

Signature
care^®
Quality Guaranteed

Non-Drowsy*
AGES 2 YEARS & OLDER

LORATADINE
ORAL SOLUTION USP
5 mg/5 mL

Antihistamine
24 Hour Relief of:

•    Sneezing
•     Runny Nose
•    Itchy, Watery Eyes
•    Itchy Throat or Nose

Contains sodium metabisulfite,
a sulfite that may cause
allergic-type reactions.

*When taken as directed.
See Drug Facts Panel.

Do not use if carton is opened, or if cap safety seal
is broken or missing.

Indoor & Outdoor Allergies

•    Dye-Free    •    Sugar-Free    •    Alcohol-Free

GRAPE FLAVOR              4 FL OZ (120 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to
Children's Claritin^®
active ingredient

NDC 21130-042-24

Signature
care^®
Quality Guaranteed

Non-Drowsy*
AGES 2 YEARS & OLDER

LORATADINE
ORAL SOLUTION
USP 5 mg/5 mL

Antihistamine

GRAPE FLAVOR

24 Hour Relief of:

•    Sneezing
•     Runny Nose
•    Itchy, Watery Eyes
•    Itchy Throat or Nose

Indoor & Outdoor Allergies
•    DYE-FREE

Contains sodium metabisulfite,
a sulfite that may cause
allergic-type reactions.

Dosing Cup Included

*When taken as directed.
See Drug Facts Panel.

4 FL OZ (120 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL)

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-042-24	Loratadine	120 mL in 1 BOTTLE	SOLUTION	120		2
21130-042-24	Loratadine	1 in 1 CARTON	SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-042	LORATADINE (LORATADINE ORAL) SOLUTION [BETTER LIVING BRANDS LLC]	2	Current NDC, 2 package rows	20230927_f7dc7a3d-6709-d7e7-e053-6394a90acde8.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Loratadine
Loratadine Oral
GRAPE
ASCORBIC ACID
GLYCERIN
MALTITOL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
PHOSPHORIC ACID
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM METABISULFITE
SORBITOL
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
21130-042	21130-042-24

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
GRAPE	6X543N684K	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
MALTITOL	D65DG142WK	IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	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.

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
A208931-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2018-06-29

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	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`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 ORAL	Better Living Brands LLC	f7dc7a3d-6709-d7e7-e053-6394a90acde8	2023-09-26	Warnings	Exact identifier ndc (package): 21130-042-24 ndc (product): 21130-042 ndc11 (package): 21130004224 spl id: b0412b0b-32e8-49a6-b62a-717290693d7e spl set id: f7dc7a3d-6709-d7e7-e053-6394a90acde8

Reported adverse events (FAERS/openFDA)#

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

Loratadine Oral Solution USP 5 mg/5 mL

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

Drug Facts

Purpose

Uses

Warnings

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL)

DailyMed RxNorm Mappings#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

NDC Codes#

Ingredients#

Source Document#

Orange Book application contexts#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#