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 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

each 5 mL 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 contact1-800-632-6900

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)
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
itchy, watery eyes
sneezing
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
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

each 5 mL 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

Call 1-800-632-6900

PROUDLY DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-062-24

Kroger_®
health

AGES
2
YEARS &
OLDER

CHILDREN'S
NON DROWSY*
Dye-Free Allergy Relief

Loratadine Oral Solution
USP, 5 mg/5 mL / Antihistamine

Indoor & Outdoor Allergies
Contains sodium metabisulfite, a sulfite that
may cause allergic-type reactions.
*When taken as directed. See Drug Facts Panel.

24 HOUR RELIEF

FOR RELIEF OF:
RUNNY NOSE
SNEEZING
ITCHY, WATERY EYES
ITCHY THROAT
OR NOSE

GRAPE
FLAVOR

4 FL OZ
(120 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle)

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-062-24

Kroger_®
health

COMPARE TO THE ACTIVE INGREDIENT
IN CHILDREN'S CLARITIN^® SYRUP 24-HOUR^†

CHILDREN'S

NON DROWSY*
Dye-Free
Allergy
Relief

AGES
2
YEARS &
OLDER

Loratadine Oral Solution
USP, 5 mg/5 mL
Antihistamine

Indoor & Outdoor Allergies
Contains sodium metabisulfite,
a sulfite that may cause
allergic-type reactions.
*When taken as directed.
See Drug Facts Panel.

DOSING CUP
INCLUDED

24 HOUR RELIEF

FOR RELIEF OF:
RUNNY NOSE
SNEEZING
ITCHY, WATERY EYES
ITCHY THROAT
OR NOSE

GRAPE
FLAVOR

4 FL OZ
(120 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

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
30142-062	30142-062-24

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

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2021-04-19	full-release	2026-05-31 23:39:52

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	KROGER COMPANY	b963d83b-584f-c447-e053-2995a90ad973	2026-07-06	Warnings	Exact identifier ndc (package): 30142-062-24 ndc (product): 30142-062 ndc11 (package): 30142006224 spl id: a0d92371-2853-4864-ade5-6a9207c843c6 spl set id: b963d83b-584f-c447-e053-2995a90ad973

Reported adverse events (FAERS/openFDA)#

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

Loratadine Oral Solution USP 5 mg/5 mL