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

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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


LEADER

NDC 70000-0163-1

Allergy Relief-D
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP
5 mg/120 mg
Antihistamine | Nasal Decongestant
Original Prescription Strength

COMPARE TO ZYRTEC-D® 12 HOUR
active ingredients*

12 Hour Relief of:
• Sinus Pressure • Nasal Congestion
• Runny Nose • Sneezing
• Itchy, Watery Eyes
• Itchy Throat or Nose

24 EXTENDED-RELEASE TABLETS (4 blister cards of 6 tablets each)

spl-cetirizine-showbox

ALLERGY RELIEF-D 
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0163
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:70000-0163-124 in 1 CARTON; Type 0: Not a Combination Product05/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09092205/02/2017
Labeler - Cardinal Health (097537435)
Registrant - Sun Pharmaceutical Industries Limited (650172430)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(70000-0163) , MANUFACTURE(70000-0163)

Revised: 7/2017
Document Id: 6a57686b-577f-4582-8ea4-9a533db38733
Set id: 6cca410a-cad1-40a0-b9ef-a750a74a4929
Version: 4
Effective Time: 20170727
 
Cardinal Health