ALLERGY RELIEF-D - cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
Available from:
Ohm Laboratories Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of nose or throat nasal congestion - runny nose - sneezing - itchy, watery eyes - itching of nose or throat - nasal congestion - reduces swelling of nasal passages - temporarily relieves sinus congestion and pressure - temporarily restores freer breathing through the nose
Authorization status:
Abbreviated New Drug Application
Authorization number:
51660-940-12, 51660-940-24

ALLERGY RELIEF-D - cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film

coated, extended release

Ohm Laboratories Inc.

----------

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

Drug Facts

Active ingredients (in each

extended-release tablet)

Purpose

Cetirizine HCl, USP 5 mg

Antihistamine

Pseudoephedrine HCl, USP 120

Nasal Decongestant

Us es

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

itching of nose or throat

nasal congestion

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 or to an

antihistamine containing hydroxyzine.

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cer tain 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.

Ask a doctor before use if you have

heart disease

thyroid disease

diabetes

glaucoma

high blood pressure

trouble urinating due to an enlarged prostate gland

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

do not use more than directed

drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

you get nervous, dizzy, or sleepless

symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding

if breast-feeding: not recommended

if pregnant: 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 at 1-800-222-1222.

Directions

do not break or chew tablet; swallow tablet whole

adults and children 12 years

and over

take 1 tablet every 12 hours;

do not take more than 2 tablets

in 24 hours.

adults 65 years and over

ask a doctor

children under 12 years of age ask a doctor

consumers with liver or

kidney disease

ask a doctor

Other information

store between 20° to 25°C (68° to 77°F)

do not use if carton is opened or if the blister unit is broken

see side panel for batch number and expiration date

Inactive ingredients

hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline

cellulose, stearic acid, titanium dioxide

Imprinting Ink Contents

ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac

glaze

Ques tions ?

call toll free 1-800-818-4555 weekdays

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Card Carton

NDC 51660-940-12

Compare To

the active ingredients of

Zyrtec-D 12Hr

Hour

Allergy Relief

Nasal Decongestant

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended-release Tablets, USP 5 mg/120 mg

Antihistamine/Nasal Decongestant

12 Hour Relief of:

Sneezing Itchy, Watery Eyes Sinus Pressure

Runny Nose Itchy Throat or Nose

Nasal Congestion

Indoor & Outdoor Allergies

ALLERGY & CONGESTION

12 Tablets (2 blister cards of 6 tablets each)

Original Prescription Strength

ALLERGY RELIEF-D

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

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:516 6 0 -9 40

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CETIRIZINE HYDRO CHLO RIDE (UNII: 6 4O0 47KTOA) (CETIRIZINE -

UNII:YO726 1ME24)

CETIRIZINE HYDROCHLORIDE

5 mg

PSEUDO EPHEDRINE HYDRO CHLO RIDE (UNII: 6 V9 V2RYJ8 N) (PSEUDOEPHEDRINE

- UNII:7CUC9 DDI9 F)

PSEUDOEPHEDRINE

HYDROCHLORIDE

120 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO XYPRO PYL CELLULO SE ( 16 0 0 0 0 0 WAMW) (UNII: RFW2ET6 71P)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

AMMO NIA (UNII: 5138 Q19 F1X)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

BUTYL ALCO HO L (UNII: 8 PJ6 1P6 TS3)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SHELLAC (UNII: 46 N10 7B71O)

HYDRO XYETHYL CELLULO SE ( 4 0 0 0 MPA.S AT 1%) (UNII: ZYD53NBL45)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND (circular)

S iz e

9 mm

Flavor

Imprint Code

9 15

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:516 6 0 -9 40 -12

2 in 1 CARTON

0 5/0 2/20 17

1

6 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Ohm Laboratories Inc.

2

NDC:516 6 0 -9 40 -24 4 in 1 CARTON

0 5/0 2/20 17

2

6 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 9 22

0 5/0 2/20 17

Labeler -

Ohm Laboratories Inc. (184769029)

Registrant -

Sun Pharmaceutical Industries Limited (650172430)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sun Pharmaceutical Industries Limited

6 50 44520 3

ANALYSIS(516 6 0 -9 40 ) , MANUFACTURE(516 6 0 -9 40 )

Revised: 5/2019

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