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NDC 51672-2119-04 Childrens Fexofenadine Hydrochloride 30 mg/5mL Details

Childrens Fexofenadine Hydrochloride 30 mg/5mL

Childrens Fexofenadine Hydrochloride is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. The primary component is FEXOFENADINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth in adults and children 2 years of age and older. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), including itching and rash in adults and children 6 months of age and older. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.

Related Packages: 51672-2119-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	51672-2119
Product ID	51672-2119_2d6e0c2a-2637-4953-815d-3ffc22fbf9c3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Childrens Fexofenadine Hydrochloride
Proprietary Name Suffix	Allergy
Non-Proprietary Name	Fexofenadine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	mg/5mL
Substance Name	FEXOFENADINE HYDROCHLORIDE
Labeler Name	Taro Pharmaceuticals U.S.A., Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208123
Listing Certified Through	2022-12-31

Package

Package Images

NDC 51672-2119-04 (51672211904)

Pricing Information	N/A
NDC Package Code	51672-2119-4
Billing NDC	51672211904
Package	1 BOTTLE in 1 CARTON (51672-2119-4) / 60 mL in 1 BOTTLE
Marketing Start Date	2017-11-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0a78e6ec-ac9f-494e-9f7d-b1002fcad89c Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Fexofenadine HCl 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

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 right away.

Directions

shake well before using
use only with enclosed dosing cup

Note: mL = milliliters
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

Other information

each 5 mL contains: sodium 9 mg
safety sealed: do not use if carton is opened or if foil inner seal on bottle is torn or missing
store between 20° and 25°C (68° and 77°F)

Inactive ingredients

artificial raspberry flavor, butylparaben, edetate disodium, maltitol solution, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose, titanium dioxide and xanthan gum

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Compare to the active

ingredient in Children's

Allegra® Allergy*

NDC 51672-2119-8

Children's

Allergy

Fexofenadine HCl

Oral Suspension,

30 mg/ 5 mL

Antihistamine

NON-DROWSY

12

Hour

Berry Flavor

2

Years

& Older

INDOOR/OUTDOOR

ALLERGY RELIEF

✓: Sneezing
✓: Runny Nose
✓: Itchy, Watery Eyes
✓: Itchy Nose or Throat

Dye free / Alcohol free / Sugar free

LIQUID

Oral Suspension

4 fl. oz.

(120 mL)

Principal Display Panel - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY

fexofenadine hydrochloride suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51672-2119
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (Fexofenadine - UNII:E6582LOH6V)	Fexofenadine Hydrochloride	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
butylparaben (UNII: 3QPI1U3FV8)
edetate disodium (UNII: 7FLD91C86K)
maltitol (UNII: D65DG142WK)
poloxamer 407 (UNII: TUF2IVW3M2)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B)
sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)
sucralose (UNII: 96K6UQ3ZD4)
titanium dioxide (UNII: 15FIX9V2JP)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51672-2119-4	1 in 1 CARTON	11/09/2017
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51672-2119-8	1 in 1 CARTON	11/09/2017
2		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:51672-2119-1	1 in 1 CARTON	11/09/2017
3		240 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208123	11/09/2017

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Revised: 11/2017

Document Id: 2d6e0c2a-2637-4953-815d-3ffc22fbf9c3

Set id: 0a78e6ec-ac9f-494e-9f7d-b1002fcad89c

Version: 4

Effective Time: 20171129

Search by Drug Name or NDC

NDC 51672-2119-04 Childrens Fexofenadine Hydrochloride 30 mg/5mL Details

Childrens Fexofenadine Hydrochloride 30 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51672-2119-04 (51672211904)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 0a78e6ec-ac9f-494e-9f7d-b1002fcad89c Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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