Childrens Allergy

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Effective date
2021-10-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:31:50

Label at a glance#

ProductChildrens Allergy
Active ingredientLORATADINE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose 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

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL 1 teaspoon)

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:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • 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,

PREGNANCY 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only with enclosed dosing cup
adults and children 6 years and over2 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

  • each teaspoonful contains: sodium 1 mg
  • store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-309-9030 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Children's Claritin® Allergy**

For Ages 2 and Older

Non-Drowsy*

Children's Allergy

LASTS 24 HOURS

Loratadine Oral Solution 5 mg / 5 mL / Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

Alcohol free

Dye free

Suger free

Provides allergy symptom relief

Grape Flavor

*When taken as directed See Drug Facts panel.

*This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Children's Claritin® Allergy

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.

DISTRIBUTED BY: DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOLLAR GENERAL Children's Allergy
DOLLAR GENERAL Children's Allergy

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-53955910-539-04

Ingredients#

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

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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077421-001LORATADINELORATADINE1MG/MLSYRUP / ORAL2006-06-29

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29c2088c7a36db…
2026-09-14 22:38:342026-08A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-2984e616aacf4f…
2026-08-18 06:07:402026-07A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077421-001LORATADINE1MG/MLSYRUP / ORAL2006-06-293a93d1ddd44b…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
de9cab09-a73a-4a1c-a87e-49d4a396e7d77e8b7d15-8bf8-487b-a103-bda3c5828ae52021-10-18WarningsExact identifier
spl id: de9cab09-a73a-4a1c-a87e-49d4a396e7d7
spl set id: 7e8b7d15-8bf8-487b-a103-bda3c5828ae5

Reported adverse events (FAERS/openFDA)#

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