Childrens Allergy

Manufacturer
Family Dollar (FAMILY WELLNESS)
Effective date
2024-06-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:13:22

Label at a glance#

ProductChildrens Allergy
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Storage and handling

each 5 mL contains: sodium 17 mg store between 20º to 25ºC (68º and 77ºF)

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCL, USP 30 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
  • sneezing
  • 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

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
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)

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.

Direction

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • use only with enclosed dosing cup
adults and children 12 years of age and overtake 10 mL every 12 hours; do not take more than 20 mL in 24 hours
children 2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 2 years of ageask a doctor
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Note: mL = milliliters

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 17 mg
  • store between 20º to 25ºC (68º and 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucrose, titanium dioxide, xanthan gum, xylitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENT IN CHILDREN'S ALLEGRA® ALLERGY*

Children's

ALLERGY

AGES 2 YEARS & UP

FEXOFENADINE HCl

ORAL SUSPENSION

30 mg/5mL

Antihistamine

Indoor/Outdoor allergy relief

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

12 Hour Relief

Non-drowsy

Alcohol-free

DYE-FREE

BERRY FLAVOR

FL OZ (mL)

Use only with enclosed dosing cup. Wash and let air dry after each use.

*This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Children's Allegra® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF SEAL ON BOTTLE  PRINTED WITH "SEALED FOR SAFETY" IS TORN OR MISSING.

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC,

500 VOLVO PKWY,

CHESAPEAKE, VA 23320

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS Children's Allergy Dye-Free Berry Flavor
FAMILY WELLNESS Children's Allergy Dye-Free Berry Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSN4
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCD4
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FEXOFENADINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-957-04Childrens Allergy1 in 1 BOXSUSPENSION14
55319-957-04Childrens Allergy118 mL in 1 BOTTLE, PLASTICSUSPENSION1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-957CHILDRENS ALLERGY (FEXOFENADINE HCL) SUSPENSION [FAMILY DOLLAR (FAMILY WELLNESS)]42 package rows20240606_ba4df76e-cbed-4e19-afc6-c76000f0bf4f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-95755319-957-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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
e5385990-9e94-42e7-9923-f2893d93bd34ba4df76e-cbed-4e19-afc6-c76000f0bf4f2024-06-04WarningsExact identifier
spl id: e5385990-9e94-42e7-9923-f2893d93bd34
spl set id: ba4df76e-cbed-4e19-afc6-c76000f0bf4f

Reported adverse events (FAERS/openFDA)#

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