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NDC 41167-4122-00 Allegra Allergy 180 mg/1 Details

Allegra Allergy 180 mg/1

Allegra Allergy is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Chattem, 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: 41167-4122-00
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	41167-4122
Product ID	41167-4122_7b02cf6b-1e6e-429f-997b-991fc71b852e
Associated GPIs	41550024100350
GCN Sequence Number	033716
GCN Sequence Number Description	fexofenadine HCl TABLET 180 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	46594
HICL Sequence Number	011595
HICL Sequence Number Description	FEXOFENADINE HCL
Brand/Generic	Brand
Proprietary Name	Allegra Allergy
Proprietary Name Suffix	n/a
Non-Proprietary Name	Fexofenadine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE
Labeler Name	Chattem, Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA020872
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41167-4122-00 (41167412200)

Pricing Information	N/A
NDC Package Code	41167-4122-0
Billing NDC	41167412200
Package	1 BLISTER PACK in 1 CARTON (41167-4122-0) / 8 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date	2014-12-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f061d6b1-89f7-4d5f-ac59-9c73408517c1 Details

SPL UNCLASSIFIED SECTION

Allegra Allergy® Gelcaps – 24 HOUR

Drug Facts

Active ingredient

(in each tablet)

Fexofenadine HCI 180 mg

Purpose

Antihistamine

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

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

adults and children 12 years of age and over	take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Other information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened
store between 20º and 25ºC (68º and 77ºF)
protect from excessive moisture

Inactive ingredients

croscarmellose sodium, D&C red 28, D&C red 33, FD&C blue 1, gelatin, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, PEG-135, pharmaceutical ink, pregelatinized starch, titanium dioxide

Questions or comments?

call toll-free 1-800-633-1610 or www.allegra.com

The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection.

Dist. By: Chattem, Inc., a Sanofi Company, Chattanooga, TN 37409-0219 ©2014

PRINCIPAL DISPLAY PANEL

NDC 41167-4122-0

Allegra®

ALLERGY

fexofenadine HCI tablet

180 mg/antihistamine

24 HR

8 GELCAPS

INGREDIENTS AND APPEARANCE

ALLEGRA ALLERGY

fexofenadine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-4122
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple (White band in the middle)	Score	no score
Shape	OVAL (Caplet)	Size	20mm
Flavor		Imprint Code	AG;AG
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-4122-5	1 in 1 CARTON	12/17/2014
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:41167-4122-6	1 in 1 CARTON	12/17/2014
2		32 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:41167-4122-9	2 in 1 CARTON	12/17/2014	06/23/2019
3	NDC:41167-4122-7	40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:41167-4122-2	1 in 1 CARTON	12/17/2014
4		60 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:41167-4122-0	1 in 1 CARTON	12/17/2014
5		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020872	12/17/2014

Labeler - Chattem, Inc. (003336013)

Revised: 8/2021

Document Id: 7b02cf6b-1e6e-429f-997b-991fc71b852e

Set id: f061d6b1-89f7-4d5f-ac59-9c73408517c1

Version: 17

Effective Time: 20210830