Childrens Allegra Allergy Oral Suspension

Childrens Allegra Allergy Oral Suspension
SPL v26
SPL
SPL Set ID e2bd23c7-dfba-463a-adbe-2183970da740
Route
ORAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (30 mg)
Inactive Ingredients
Edetate Disodium Poloxamer 407 Propylene Glycol Water Sodium Phosphate, Dibasic, Heptahydrate Sodium Phosphate, Monobasic, Monohydrate Sucrose Titanium Dioxide Xanthan Gum Potassium Sorbate Xylitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
NDA Active Since 2011-03-03

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose

  • sneezing

  • itchy, water eyes

  • itching of the nose or throat
Section 42229-5

Drug Facts

Directions
  • 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.

Active Ingredient

(in each 5 mL )

Fexofenadine HCI 30 mg

Other Information
  • each 5 mL contains: each 5 mL contains: potassium 5 mg and sodium 19 mg

  • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

  • store between 20° and 25°C (68° and 77°F)

  • color change from white to beige is expected over time. This does not impact product effectiveness and safety.
Inactive Ingredients

edetate disodium, flavor, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, titanium dioxide, xanthan gum, xylitol

Questions Or Comments?

call toll-free 1-800- 844 - 2798 

Principal Display Panel

NDC 41167-4244-4

Children’s

Allegra®

ALLERGY

fexofenadine HCI

oral suspension

12 HR

30 mg/5 ml antihistamine

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 right away.

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, water eyes

  • itching of the nose or throat
Section 42229-5 (42229-5)

Drug Facts

Purpose

Antihistamine

Directions
  • 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.

Active Ingredient (Active ingredient)

(in each 5 mL )

Fexofenadine HCI 30 mg

Other Information (Other information)
  • each 5 mL contains: each 5 mL contains: potassium 5 mg and sodium 19 mg

  • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

  • store between 20° and 25°C (68° and 77°F)

  • color change from white to beige is expected over time. This does not impact product effectiveness and safety.
Inactive Ingredients (Inactive ingredients)

edetate disodium, flavor, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, titanium dioxide, xanthan gum, xylitol

Questions Or Comments? (Questions or comments?)

call toll-free 1-800- 844 - 2798 

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 41167-4244-4

Children’s

Allegra®

ALLERGY

fexofenadine HCI

oral suspension

12 HR

30 mg/5 ml antihistamine

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 right away.

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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