ALLERGY RELIEF-D - cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Ohm Laboratories Inc.

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Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

Drug Facts

Active ingredients (in each extended-release tablet)Purposes
Cetirizine HCl, USP 5 mgAntihistamine
Pseudoephedrine HCl, USP 120 mgNasal Decongestant

Uses

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) (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.

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

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

Manufactured by:
Sun Pharmaceutical Industries Limited
Survey No. 1012, Dadra-396 193,
U.T. of D & NH and Daman & Diu, India.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Card Carton

Compare To
the active ingredients of
Zyrtec-D®12Hr

NDC 51660-940-12

ohm®

12
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 & SINUS

12 Tablets (2 blister cards of 6 tablets each)

Original Prescription Strength

PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Card Carton
ALLERGY RELIEF-D 
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-940
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)  
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)  
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:51660-940-122 in 1 CARTON05/02/2017
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51660-940-244 in 1 CARTON05/02/2017
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09092205/02/2017
Labeler - Ohm Laboratories Inc. (184769029)
Registrant - Sun Pharmaceutical Industries Limited (650172430)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203MANUFACTURE(51660-940)

Revised: 12/2023
Document Id: abfd39a3-e6e1-443e-b867-2571c1e03ca3
Set id: c24f3760-70e0-410f-bf80-6d0cadcd61b9
Version: 4
Effective Time: 20231215
 
Ohm Laboratories Inc.