CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE- cetirizine hydrochloride, pseudoephedrine hydrochloride tablet, film coated, extended release

Cetirizine hydrochloride and Pseudoephedrine hydrochloride by

Drug Labeling and Warnings

Cetirizine hydrochloride and Pseudoephedrine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Perrigo New York Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal decongestant

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the 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) (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. (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 blister unit is broken or torn
• see side panel for lot number and expiration date
• meets USP Dissolution Test 2

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Zyrtec-D®

active ingredients

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended Release Tablets

5 mg/120 mg

Antihistamine / Nasal Decongestant

12 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

Sinus Pressure

Nasal Congestion

Original Prescription Strength

actual size

Indoor & Outdoor Allergies

12 Extended Release Tablets

Allergy & Congestion

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
cetirizine hydrochloride, pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45802-147
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	L147
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45802-147-53	12 in 1 CARTON	03/31/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 45802-147-62	24 in 1 CARTON	03/31/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210719	03/31/2020

Labeler - Perrigo New York Inc (078846912)