Search by Drug Name or NDC

NDC 46122-0694-65 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1 Details

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by AmeriSource Bergen. The primary component is FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

The combination of fexofenadine and pseudoephedrine is used in adults and children 12 years of age and older to relieve the allergy symptoms of seasonal allergic rhinitis ('hay fever'), including runny nose; sneezing; congestion (stuffy nose); red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth. 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. Pseudoephedrine is in a class of medications called decongestants. It works by drying up the nasal passages.

Related Packages: 46122-0694-65
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine and Pseudoephedrine

Product Information

NDC	46122-0694
Product ID	46122-694_e1aa7e23-30a8-46dd-bfaa-ef3428447c60
Associated GPIs	43993002687420
GCN Sequence Number	036868
GCN Sequence Number Description	fexofenadine/pseudoephedrine TAB ER 12H 60MG-120MG ORAL
HIC3	Z2O
HIC3 Description	2ND GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	63565
HICL Sequence Number	016846
HICL Sequence Number Description	FEXOFENADINE HCL/PSEUDOEPHEDRINE HCL
Brand/Generic	Generic
Proprietary Name	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	60; 120
Active Ingredient Units	mg/1; mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	AmeriSource Bergen
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090818
Listing Certified Through	2024-12-31

Package

Package Images

NDC 46122-0694-65 (46122069465)

Pricing Information
NDC Package Code	46122-694-65
Billing NDC	46122069465
Package	3 BLISTER PACK in 1 CARTON (46122-694-65) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2018-03-01
NDC Exclude Flag	N
Price Per Unit	0.47685
Pricing Unit	EA
Effective Date	2023-08-23
NDC Description	GNP FEXOFENADINE-PSE ER 60-120
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 4a8df3c9-bed3-4371-a1c1-59afe12203e2 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each extended-release tablet)	Purpose
Fexofenadine HCl, USP 60 mg	Antihistamine
Pseudoephedrine HCl, USP 120 mg	Nasal Decongestant

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
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have difficulty swallowing

Ask a doctor before use if you have

heart disease
thyroid disease
glaucoma
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
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.
symptoms do not improve within 7 days or are accompanied by a fever
you get nervous, dizzy, or sleepless

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 (1800-222-1222).

Directions

do not divide, crush, chew or dissolve the tablet; swallow tablet whole

adults and children 12 years of age and over	take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets 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

do not use if carton is opened or if individual blister units are torn or opened
store between 20° to 25°C (68° to 77°F)
USP dissolution test is pending.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

Questions or comments?

Call toll-free 1-800-818-4555 weekdays

SPL UNCLASSIFIED SECTION

Distributed By:

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

Compare to Allegra-D® active ingredients**

Rx

GOOD

NEIGHBOR

PHARMACY®

NDC 46122-694-65

Original Prescription Strength

NON-DROWSY

12 HOUR

fexofenadine HCl 60 mg/antihistamine

pseudoephedrine HCl 120 mg/nasal decongestant

Extended-Release Tablets, USP

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies
Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or

Throat Due to Allergies

30 Extended-Release Tablets

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-694
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	WHITE, YELLOW	Score	no score
Shape	CAPSULE (bilayer)	Size	17mm
Flavor		Imprint Code	724
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:46122-694-65	3 in 1 CARTON	03/01/2018
1		10 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
ANDA	ANDA090818	03/01/2018

Labeler - AmeriSource Bergen (007914906)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Pharmaceutical Industries Limited		650445203	ANALYSIS(46122-694) , MANUFACTURE(46122-694)

Revised: 4/2021

Document Id: e1aa7e23-30a8-46dd-bfaa-ef3428447c60

Set id: 4a8df3c9-bed3-4371-a1c1-59afe12203e2

Version: 1

Effective Time: 20210428

Search by Drug Name or NDC

NDC 46122-0694-65 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1 Details

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 46122-0694-65 (46122069465)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4a8df3c9-bed3-4371-a1c1-59afe12203e2 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

Migranal Generic Name Question

Can You Take A Z-Pak If You Have A Penicillin Allergy?