CETIRIZINE HYDROCHLORIDE AND 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 Sun Pharmaceutical Industries, Inc., Sun Pharmaceutical Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Cetirizine HCl, USP 5 mg
Pseudoephedrine HCl, USP 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) (cer tain 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.

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 inner safety seal is open or torn
• see top layer for lot 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

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 & CONGESTION
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
12 Tablets (2 blister cards of 6 tablets each)

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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62756-915
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (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
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: 62756-915-83	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/29/2012
2	NDC: 62756-915-63	1 in 1 CARTON	09/29/2012
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 62756-915-62	2 in 1 CARTON	09/29/2012
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 62756-915-73	4 in 1 CARTON	09/29/2012
4		6 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	ANDA090922	09/29/2012

Labeler - Sun Pharmaceutical Industries, Inc. (146974886)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharmaceutical Industries Limited		650445203	ANALYSIS(62756-915) , MANUFACTURE(62756-915)