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

Allergy relief-D by

Drug Labeling and Warnings

Allergy relief-D by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG CONSORTIUM,LLC, Sun Pharmaceutical Industries Limited , Sun Pharmaceutical Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each extended-release tablet)	Purpose
Cetirizine HCl, USP 5 mg	Antihistamine
Pseudoephedrine HCl, USP 120 mg	Nasal Decongestant

Uses

• 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 af ter 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

Questions?

Call toll free 1-800-818-4555 weekdays

SPL UNCLASSIFIED SECTION

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

*COMPARE TO THE
ACTIVE INGREDIENTS
IN ZYRTEC-D 12 HOUR®

Original Prescription Strength

Premier
Value®

Allergy & Congestion Relief

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-release Tablets, USP

5 mg/120 mg

Antihistamine/Nasal Decongestant
Indoor & Outdoor Allergies

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

24 TABLETS
(4 blister cards of 6 tablets each)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-531
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	ROUND (circular)	Size	9mm
Flavor		Imprint Code	915
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-531-24	24 in 1 CARTON; Type 0: Not a Combination Product	08/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090922	08/17/2016

Labeler - CHAIN DRUG CONSORTIUM,LLC (101668460)

Registrant - Sun Pharmaceutical Industries Limited (650172430)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharmaceutical Industries Limited		650445203	ANALYSIS(68016-531) , MANUFACTURE(68016-531)