Equaline Childrens Allergy Relief

Manufacturer
United Natural Foods, Inc. dba UNFI
Effective date
2023-08-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:56:21

Label at a glance#

ProductEqualine Childrens Allergy Relief
Active ingredientLORATADINE
Label structure9 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

• chew or crush tablets completely before swallowing adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet 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 tablet)

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

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or crush tablets completely before swallowing

adults and children 6 years and over

chew 2 tablets daily; not more than 2 tablets in 24 hours

children 2 to under 6 years of age

chew 1 tablet daily; not more than 1 tablet in 24 hours

children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

OTHER SAFETY INFORMATION

  • phenylketonurics: contains phenylalanine 1.4 mg per tablet
  • do not use if blister unit is broken or torn
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-855-423-2630

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compare to Children’s Claritin® Chewables

active ingredient

children’s allergy relief

loratadine chewable tablets, 5 mg (antihistamine)

indoor & outdoor allergies

non-drowsy*

24 hour relief of:

sneezing

runny nose

itchy, watery eyes

itchy throat or nose

ages 2 years and older

actual size

20 chewable tablets

grape flavor

*WHEN TAKEN AS DIRECTED.

SEE DRUG FACTS PANEL

3y8-el-allergy-relief
3y8-el-allergy-relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN4
665078loratadine 5 MG Chewable TabletSCD4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-364-01Equaline Childrens Allergy Relief1 in 1 BLISTER PACKTABLET, CHEWABLE14
41163-364-01Equaline Childrens Allergy Relief20 in 1 CARTONTABLET, CHEWABLE204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-364EQUALINE CHILDRENS ALLERGY RELIEF (LORATADINE) TABLET, CHEWABLE [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, Legacy NDC, 2 package rows20231003_25329c7d-76e7-47b3-914e-ac367bbb750b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-36441163-364-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 43.

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
A210033-001LORATADINELORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1284e616aacf4f…
2026-08-18 06:07:402026-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123f01610625f2…
2019-09-15 20:21 UTC2019-09A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12f41ea6bd6efb…

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
Equaline Childrens Allergy ReliefLORATADINEUnited Natural Foods, Inc. dba UNFI25329c7d-76e7-47b3-914e-ac367bbb750b2023-08-17WarningsExact identifier
ndc (package): 41163-364-01
ndc (product): 41163-364
ndc11 (package): 41163036401
spl id: 0a4f60cb-fb2e-4b71-bad6-13d532f9821e
spl set id: 25329c7d-76e7-47b3-914e-ac367bbb750b

Reported adverse events (FAERS/openFDA)#

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