CETIRIZINE HYDROCHLORIDE tablet

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Warnings

Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have 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

• 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.

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

• adults and children 6 years and over:

  One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

• adults 65 years and over:

  ask a doctor

• children under 6 years of age:

  ask a doctor

• consumers with liver or kidney disease:

  ask a doctor

Other information

• Store between 20º to 25º C (68º to 77º F)

Inactive ingredients

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.06/2013

HOW SUPPLIED

Product: 71335-0028

NDC: 71335-0028-1 30 TABLET in a BOTTLE

NDC: 71335-0028-2 14 TABLET in a BOTTLE

NDC: 71335-0028-3 7 TABLET in a BOTTLE

NDC: 71335-0028-4 10 TABLET in a BOTTLE

NDC: 71335-0028-5 15 TABLET in a BOTTLE

NDC: 71335-0028-6 90 TABLET in a BOTTLE

NDC: 71335-0028-7 20 TABLET in a BOTTLE

NDC: 71335-0028-8 60 TABLET in a BOTTLE

NDC: 71335-0028-9 100 TABLET in a BOTTLE

Cetirizine Hcl 10mg Tablet

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-0028(NDC:0781-1684)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	WHITE (white to off-white)	Score	no score
Shape	ROUND (round shape)	Size	8mm
Flavor		Imprint Code	SZ;906
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-0028-4	10 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2010
2	NDC: 71335-0028-7	20 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2010
3	NDC: 71335-0028-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2010
4	NDC: 71335-0028-2	14 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2010
5	NDC: 71335-0028-8	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2010
6	NDC: 71335-0028-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2010
7	NDC: 71335-0028-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2010
8	NDC: 71335-0028-9	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2010
9	NDC: 71335-0028-3	7 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077946	12/27/2007

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0028) , RELABEL(71335-0028)