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NDC 55111-0557-35 Fexofenadine HCl and Pseudoephedrine HCI 180; 240 mg/1; mg/1 Details

Fexofenadine HCl and Pseudoephedrine HCI 180; 240 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 Limited. 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: 55111-0557-35
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine and Pseudoephedrine

Product Information

NDC	55111-0557
Product ID	55111-557_29216032-68a5-566a-5eaf-ffc9cb597e9a
Associated GPIs	43993002687520
GCN Sequence Number	058869
GCN Sequence Number Description	fexofenadine/pseudoephedrine TAB ER 24H 180-240MG ORAL
HIC3	Z2O
HIC3 Description	2ND GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	24394
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	180; 240
Active Ingredient Units	mg/1; mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Dr.Reddy's Laboratories Limited
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	ANDA079043
Listing Certified Through	2024-12-31

Package

Package Images

NDC 55111-0557-35 (55111055735)

Pricing Information	N/A
NDC Package Code	55111-557-35
Billing NDC	55111055735
Package	2 BLISTER PACK in 1 CARTON (55111-557-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2011-08-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 25cca459-fdd6-3847-2207-dd4f019781b5 Details

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Pseudoephedrine HCl USP, 240 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 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 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 24 hours on an empty stomach; 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 20° - 25°C (68° - 77°F)
this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

acetyltributyl citrate, colloidal silicon dioxide, copovidone, croscarmellose sodium, ethylcellulose, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.

Questions?

Call 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Blister carton label : 10's

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:55111-557
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
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	240 mg

Ingredient Name	Strength
Inactive Ingredients
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
COPOVIDONE (UNII: D9C330MD8B)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	RDY;572
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-557-07	1 in 1 CARTON	08/24/2011
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:55111-557-35	2 in 1 CARTON	08/24/2011
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:55111-557-29	3 in 1 CARTON	08/24/2011
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	ANDA079043	08/24/2011

Labeler - Dr.Reddy's Laboratories Limited (650562841)

Name	Address	ID/FEI	Business Operations
Establishment
Dr.Reddy's Laboratories Limted (FTO III)		918608162	analysis(55111-557) , manufacture(55111-557)

Revised: 12/2018

Document Id: 29216032-68a5-566a-5eaf-ffc9cb597e9a

Set id: 25cca459-fdd6-3847-2207-dd4f019781b5

Version: 9

Effective Time: 20181205