Children Allergy

FEXOFENADINE HCL ORAL HUMAN OTC DRUG

Children Allergy is an FDA drug label for the active ingredient FEXOFENADINE HCL manufactured by H E B administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260512.

Generic name
FEXOFENADINE HCL
Manufacturer
H E B
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
37808-654
Application
ANDA203330
Label effective
20260512

About this product

Children Allergy is an FDA-registered drug product whose active ingredient is FEXOFENADINE HCL. It is labelled by H E B taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 37808-654, application ANDA203330, label effective 20260512. It is one of 31 FDA drug label records sharing the active ingredient FEXOFENADINE HCL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing FEXOFENADINE HCL are most often described in connection with: temporarily relieves, symptoms due, hay fever, upper respiratory, allergies runny, nose sneezing, itchy watery, eyes itching. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each 5 mL) Fexofenadine HCl, USP 30 mg

Indications & Usage

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

Dosage & Administration

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

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 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.

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How products containing FEXOFENADINE HCL compare

FDA lists 31 drug label records with FEXOFENADINE HCL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — A-S Medication Solutions 3
— — Allegiant Health 3
— — PLD Acquisitions LLC DBA Avma Pharma Solutions 3
— — CVS PHARMACY, INC 2
— — Camber Consumer Care 2

Frequently asked questions

What is Children Allergy used for?
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

Who makes Children Allergy?
H E B is the labeler of record for Children Allergy. 31 FDA label records share the active ingredient FEXOFENADINE HCL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Children Allergy come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Children Allergy prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FEXOFENADINE HCL?
Yes. 31 FDA drug label records list FEXOFENADINE HCL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Children Allergy been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.