Allergy Relief-D: Package Insert and Label Information

ALLERGY RELIEF-D — cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
CHAIN DRUG CONSORTIUM,LLC

Drug Facts

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

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

Principal Display Panel -- 24 Tablet Blister Pack Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
Product Characteristics
Color WHITE Score no score
Shape ROUND (circular) Size 9mm
Flavor Imprint Code 915
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68016-531-24 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON None
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 Operations
Sun Pharmaceutical Industries Limited 650445203 ANALYSIS (68016-531), MANUFACTURE (68016-531)

Revised: 11/2018 CHAIN DRUG CONSORTIUM,LLC

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