Perrigo Children’s Allergy Relief Drug Facts

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-05-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-06-03 18:03:30

Label at a glance#

ProductGood Sense childrens allergy relief
Active ingredientLORATADINE
Label structure12 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 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 • do not use if carton is opened, or if printed ne...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL teaspoonful)

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

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

  • 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

  • do not use if carton is opened, or if printed neckband is broken or missing
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ages 2 Years and Older

Non-Drowsy*

Children’s Allergy Relief

Loratadine Oral Solution, 5 mg/5 mL

Antihistamine

Indoor & Outdoor Allergies

Dye-Free

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Grape Flavor

*When taken as directed.

See Drug Facts Panel.

Compare to active ingredient of Children’s Claritin®

100% SATISFACTION GUARANTEED

4 FL OZ (120 mL)

Relabeled By: Preferred Pharmaceuticals Inc.

Loratadine Oral Solution 5mg/5mL
Loratadine Oral Solution 5mg/5mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN4
692783loratadine 1 MG/ML Oral SolutionSCD4
692783loratadine 5 MG per 5 ML Oral SolutionSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128565image-01.jpg
Data codeData Matrix**072325*image-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8657-1ML - Milliliter68788-8657b847475a-aa83-49d7-b60d-ab1beba849b712024-06-10
0113-0671-26ML - Milliliter0113-0671405095bb-e2dd-4a7b-a83a-e17a1fe30e3f12022-03-09

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-865768788-8657-1
0113-0671

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-07-23full-release2026-06-01 01:08:24

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
A075728-001LORATADINELORATADINE1MG/MLSYRUP / ORAL2004-08-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2084e616aacf4f…
2026-08-18 06:07:402026-07A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203f01610625f2…
2019-09-15 20:21 UTC2019-09A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense childrens allergy reliefLORATADINEPreferred Pharmaceuticals Inc.27bb0a40-35ee-4c19-bd6f-fb054c8a25862026-05-28WarningsExact identifier
ndc (package): 68788-8657-1
ndc (product): 68788-8657
ndc11 (package): 68788865701
spl id: 848b8687-3bac-4a69-98a5-6d00a85f2953
spl set id: 27bb0a40-35ee-4c19-bd6f-fb054c8a2586
Good Sense childrens allergy reliefLORATADINEL. Perrigo Company637e309d-9846-45a1-ad11-f67ea85c87b82025-05-05WarningsExact identifier
ndc (product): 0113-0671

Reported adverse events (FAERS/openFDA)#

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