CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Sun Pharmaceutical Industries, Inc.

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Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

Active ingredients

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

Purposes

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 (1-800-222-1222).

Directions

adults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and overask a doctor
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask 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 62756-915-62

Original Prescription Strength
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP
5 mg/120 mg
Antihistamine/Nasal Decongestant
Indoor & Outdoor Allergies
ALLERGY & SINUS
SUN PHARMA
Actual Size
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
12 Tablets (2 blister cards of 6 tablets each)

13

Principal Display Panel - Blister pack

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP

5 mg/120 mg

Mfg. by: Sun Pharmaceutical Ind. Ltd. India.

spl-cetirizine-pseudoephedrine-blister

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-915
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 (1600000 WAMW) (UNII: RFW2ET671P)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (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)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (circular) Size9mm
FlavorImprint Code 915
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62756-915-622 in 1 CARTON09/29/2012
1NDC:62756-915-606 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:62756-915-734 in 1 CARTON09/29/2012
2NDC:62756-915-606 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09092209/29/2012
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-915) , MANUFACTURE(62756-915)

Revised: 11/2024
Document Id: a0bd1e9b-eb9f-46e7-8cee-10bde092d7cb
Set id: 796c4b81-145b-4050-a851-dec81ff97006
Version: 11
Effective Time: 20241127
 
Sun Pharmaceutical Industries, Inc.