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NDC 62756-0915-63 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5; 120 mg/1; mg/1 Details

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5; 120 mg/1; mg/1

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 62756-0915-63
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Related Packages: 62756-0915-63
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	62756-0915
Product ID	62756-915_7d3c263b-b35c-44de-8971-2ed79b325a58
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	5; 120
Active Ingredient Units	mg/1; mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Sun Pharmaceutical Industries, Inc.
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090922
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62756-0915-63 (62756091563)

Pricing Information	N/A
NDC Package Code	62756-915-63
Billing NDC	62756091563
Package	1 BLISTER PACK in 1 CARTON (62756-915-63) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60)
Marketing Start Date	2012-09-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 796c4b81-145b-4050-a851-dec81ff97006 Details

Active ingredients

Cetirizine HCl, USP 5 mg

Pseudoephedrine HCl, USP 120 mg

Purposes

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 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 (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

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 & SINUS

SUN PHARMA

Actual Size

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (circular)	Size	9mm
Flavor		Imprint Code	915
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
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	NDC:62756-915-60	6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:62756-915-62	2 in 1 CARTON	09/29/2012
3	NDC:62756-915-60	6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:62756-915-73	4 in 1 CARTON	09/29/2012
4	NDC:62756-915-60	6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090922	09/29/2012

Labeler - Sun Pharmaceutical Industries, Inc. (146974886)

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

Revised: 7/2022

Document Id: 7d3c263b-b35c-44de-8971-2ed79b325a58

Set id: 796c4b81-145b-4050-a851-dec81ff97006

Version: 9

Effective Time: 20220701