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NDC 58602-0807-83 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 Aurohealth LLC. 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: 58602-0807-83
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine and Pseudoephedrine

Product Information

NDC	58602-0807
Product ID	58602-807_b11d0f1c-af6e-4e8b-bc4e-7ea188a69ff2
Associated GPIs
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	Aurohealth LLC
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	ANDA209116
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58602-0807-83 (58602080783)

Pricing Information	N/A
NDC Package Code	58602-807-83
Billing NDC	58602080783
Package	1 BLISTER PACK in 1 CARTON (58602-807-83) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2017-10-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4726af84-83c1-456d-995c-f6a8d1583f8b Details

Drug Facts

Active ingredients (in each tablet)

Fexofenadine HCl USP 60 mg

Pseudoephedrine HCl USP 120 mg

Purpose

Antihistamine

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)
the tablet coating may be seen in the stool (this is normal). Continue to take as directed (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 (1-800-222-1222) 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 at 20-25°C (68-77°F).
Meets USP dissolution test 7

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid

Questions or Comments?

call 1-855-274-4122

IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.

Manufactured for:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 10 Blister Carton

AUROHEALTH

NDC 58602-807-83

*Compare to the active ingredients

in Allegra-D® 12 Hour

Allergy & Congestion Tablets

Allergy & Congestion

Fexofenadine HCl and Pseudoephedrine HCl

Extended-Release Tablets USP 60 mg / 120 mg

Fexofenadine HCl 60 mg / antihistamine

Pseudoephedrine HCl 120 mg / nasal decongestion

12 HOUR

Non-Drowsy

Indoor / Outdoor 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

10 Extended Release Tablets

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:58602-807
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	YELLOW (White to Off White Layer and Yellow to Pale Yellow)	Score	no score
Shape	CAPSULE (Bincovex)	Size	19mm
Flavor		Imprint Code	Z;79
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-807-83	1 in 1 CARTON	10/30/2017
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:58602-807-67	2 in 1 CARTON	10/30/2017
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:58602-807-84	3 in 1 CARTON	10/30/2017
3		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	ANDA209116	10/30/2017

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-807) , MANUFACTURE(58602-807)

Revised: 8/2022

Document Id: b11d0f1c-af6e-4e8b-bc4e-7ea188a69ff2

Set id: 4726af84-83c1-456d-995c-f6a8d1583f8b

Version: 5

Effective Time: 20220804