CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE - cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Chain Drug Marketing Association, Inc.

----------

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

Drug Facts

Active ingredients


Cetirizine HCl, USP 5 mg
Pseudoephedrine HCl, USP 120 mg

Purpose


Antihistamine
Nasal Decongestant

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are


taking tranquilizers or sedatives.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding:

Keep out of reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

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

Questions?


Call toll free 1-800-818-4555 weekdays

Principal Display Panel - Showbox


NDC 63868-964-24
*Compare to the active Ingredient in ZYRTEC-D®
Original Prescription Strength
Allergy Relief-D
Cetirizine HCl and Pseudoephedrine HCl Extended-release Tablets, USP
5 mg/120 mg

Indoor & Outdoor Allergies

ALLERGY & CONGESTION
12 Hour Relief of:
Sneezing
Itchy, Watery Eyes
Runny Nose
Sinus Pressure 
Itching Throat or nose
Nasal Congestion

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
24 Tablets (4 blister cards of 6 tablets each)
QUALITY CHOICE

spl-cetrizine-psedoephedrine

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-964
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
AMMONIA (UNII: 5138Q19F1X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (circular) Size9mm
FlavorImprint Code 915
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-964-244 in 1 CARTON03/03/2016
1NDC:63868-964-736 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09092203/03/2016
Labeler - Chain Drug Marketing Association, Inc. (011920774)
Registrant - Sun Pharmaceutical Industries Limited (650172430)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(63868-964) , MANUFACTURE(63868-964)

Revised: 6/2016
Document Id: 18f49be0-7363-4791-8e46-ffc2a11e7286
Set id: b83d0d38-442c-41ee-88c3-51690edbcd91
Version: 2
Effective Time: 20160629
 
Chain Drug Marketing Association, Inc.