Childrens Allergy Suspension
FDA Label NDC 61269-527

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H2-pharma, Llc for the product Childrens Allergy (NDC 61269-527). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml), purpose, uses, otc - do not use, otc - ask doctor, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

Active Ingredient (In Each 5 Ml)

Fexofenadine HCl, USP 30 mg

Purpose

Antihistamine

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

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Otc - Ask Doctor

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)

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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.

Directions

  • shake well before using
  • use only with enclosed dosing cup
    • Note: mL = milliliters
    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

Other Information

  • each 5 mL contains: sodium 18 mg
  • store between 20° to 25°C (68° to 77°F)
  • before using any medication, read all label directions. Keep carton, it contains important information.

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

Questions Or Comments?

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

Principal Display Panel - 237 Ml Bottle Carton

NDC 61269-527-98

*Compare to the active ingredient
in Children's Allegra® Allergy

Children's
Allergy

Fexofenadine HCl
Oral Suspension 30 mg/5 mL

Antihistamine

Indoor/Outdoor allergy relief
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat

12 Hour Relief
Ages 2 years and older
Non-drowsy
Dye-free
Alcohol-free

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

BERRY FLAVOR

8 fl oz (237 mL)

H2 pharma

Principal Display Panel (237 mL Bottle Carton)

Principal Display Panel (237 mL Bottle Carton)

* Please review the disclaimer below.