Search by Drug Name or NDC

NDC 43598-0823-35 Fexofenadine HCl and Pseudoephedrine HCI 60; 120 mg/1; mg/1 Details

Fexofenadine HCl and Pseudoephedrine HCI 60; 120 mg/1; mg/1

Fexofenadine HCl and Pseudoephedrine HCI is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Reddy's Laboratories Inc.. 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: 43598-0823-35
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine and Pseudoephedrine

Product Information

NDC	43598-0823
Product ID	43598-823_d024126e-de41-3d5e-73d8-bbb2623037e6
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 HCl and Pseudoephedrine HCI
Proprietary Name Suffix	n/a
Non-Proprietary Name	Fexofenadine HCl and Pseudoephedrine HCI
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	60; 120
Active Ingredient Units	mg/1; mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Dr. Reddy's Laboratories Inc.
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	ANDA076667
Listing Certified Through	2024-12-31

Package

Package Images

NDC 43598-0823-35 (43598082335)

Pricing Information
NDC Package Code	43598-823-35
Billing NDC	43598082335
Package	2 BLISTER PACK in 1 CARTON (43598-823-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2019-10-31
NDC Exclude Flag	N
Price Per Unit	0.47685
Pricing Unit	EA
Effective Date	2023-08-23
NDC Description	FEXOFENADINE-PSE ER 60-120 TAB
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 6fd05737-d996-b5b6-dccf-bc179a9d606c Details

Active ingredient(s)

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP,120 mg

Purpose

Antihistamine

Nasal decongestant

Use(s)

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 relives 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)
the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask 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.

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

safety sealed: 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) store between 20° to 25°C (68° to 77°F)
this product meets the requirements of USP dissolution test 3.

Inactive ingredients

corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose and triethyl citrate.

Questions?

Call 1-888-375-3784

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Made in India

Principal Display Panel

Blister carton

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI

fexofenadine hcl and pseudoephedrine hci tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43598-823
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
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	WHITE (buff white to pale yellow color and other layer light red to red color)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	R;195
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43598-823-14	4 in 1 CARTON	07/18/2019
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:43598-823-31	6 in 1 CARTON	07/18/2019
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:43598-823-35	2 in 1 CARTON	10/31/2019
3		5 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	ANDA076667	07/18/2019

Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 9/2019

Document Id: d024126e-de41-3d5e-73d8-bbb2623037e6

Set id: 6fd05737-d996-b5b6-dccf-bc179a9d606c

Version: 5

Effective Time: 20190909