MedPath

Children Allergy

DRUG FACTS

Approved
Approval ID

30517ea8-0a97-4c8f-ad95-739a103784c5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

Walgreens

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fexofenadine HCL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-2600
Application NumberANDA203330
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fexofenadine HCL
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (13)

FEXOFENADINE HYDROCHLORIDEActive
Quantity: 30 mg in 5 mL
Code: 2S068B75ZU
Classification: ACTIB
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Code: KH7I04HPUU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

Product Label

![Fexofenadine HCl, USP 30 mg](/dailymed/image.cfm?name=childrens- fexofenadine-hcl-berry-liquid-mia-delist-1.jpg&id=895743)

WALGREENS Children's Allergy Relief Berry Flavor

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/2/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/2/2025

Active ingredient (in each 5 mL)

Fexofenadine HCl, USP 30 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/2/2025

Purpose

Antihistamine

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/2/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/2/2025

Questions or comments?

Call1-877-753-3935Monday-Friday 9AM-5PM EST

WARNINGS SECTION

LOINC: 34071-1Updated: 9/2/2025

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

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

When using this product

  • 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

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/2/2025

Direction

  • shake well before using
  • use only with enclosed dosing cup

adults and children 12 years of age and over

take 10 mL every 12 hours; do not take more than 20 mL in 24 hours

children 2 to under 12 years of age

take 5 mL every 12 hours; do not take more than 10 mL in 24 hours

children under 2 years of age

ask a doctor

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

Note: mL = milliliters

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/2/2025

Other information

*each 5 mL contains: sodium 17 mg

  • store between 20º to 25ºC (68º and 77ºF)

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