Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID fb163eea-b2d2-4f52-9123-0bbe28baf757
Route
ORAL
Published
Effective Date 2024-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (30 mg)
Inactive Ingredients
Butylparaben Edetate Disodium Poloxamer 407 Propylene Glycol Propylparaben Water Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate, Monobasic, Anhydrous Sucrose Titanium Dioxide Xanthan Gum Xylitol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-03-01

Description

Fexofenadine HCl, USP 30 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl, USP 30 mg

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
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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Product Label
EQUATE Children's Allergy Relief Berry Flavor
Other Information
  • each 5 mL contains: sodium 17 mg
  • store between 20º to 25ºC (68º to 77ºF)
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 1-888-287-1915

Principal Display Panel

Compare to Children's Allegra® Allergy active ingredient*

Childrens

ALLERGY RELIEF

Fexofenadine HCl Oral Suspension

30 mg/5mL

Antihistamine

Non-Drowsy

Alcohol-Free Dye-Free

AGES 2 YEARS AND OLDER

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

Indoor / Outdoor

Berry Flavor

FL OZ (mL)

Dosing Cup Enclosed

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, owner of the registered trademark 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.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY:

Walmart Inc.,

Bentonville,  AR 72716



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.

Active Ingredient (in Each 5 Ml)

Fexofenadine HCl, USP 30 mg

Ask A Doctor Before Use If You Have

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


Structured Label Content

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
Purpose

Antihistamine

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Product Label
EQUATE Children's Allergy Relief Berry Flavor
Other Information (Other information)
  • each 5 mL contains: sodium 17 mg
  • store between 20º to 25ºC (68º to 77ºF)
Inactive Ingredients (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? (Questions or comments?)

Call 1-888-287-1915

Principal Display Panel

Compare to Children's Allegra® Allergy active ingredient*

Childrens

ALLERGY RELIEF

Fexofenadine HCl Oral Suspension

30 mg/5mL

Antihistamine

Non-Drowsy

Alcohol-Free Dye-Free

AGES 2 YEARS AND OLDER

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

Indoor / Outdoor

Berry Flavor

FL OZ (mL)

Dosing Cup Enclosed

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, owner of the registered trademark 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.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY:

Walmart Inc.,

Bentonville,  AR 72716



When Using This Product (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 (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Fexofenadine HCl, USP 30 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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


Advanced Ingredient Data


Raw Label Data

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