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

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

Uses

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

Warnings

Warnings

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

liver or kidney disease. Your doctor should determine if you need a different dose.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

Directions And Dosage

Directions

• 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 Label Information

Inactive ingredients

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

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.

Label Images#

image-01
image-01

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

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#

NDC Codes#

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

Ingredients#

Complete SPL Sections#

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

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

• 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

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

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.

Source Document#

Source XML

Older Hydrated Versions#

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