CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Bryant Ranch Prepack

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Drug Facts

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

Label Image
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0028(NDC:0781-1684)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (round shape) Size8mm
FlavorImprint Code SZ;906
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0028-410 in 1 BOTTLE; Type 0: Not a Combination Product04/02/201001/12/2023
2NDC:71335-0028-720 in 1 BOTTLE; Type 0: Not a Combination Product04/02/201001/12/2023
3NDC:71335-0028-130 in 1 BOTTLE; Type 0: Not a Combination Product04/02/201001/12/2023
4NDC:71335-0028-214 in 1 BOTTLE; Type 0: Not a Combination Product04/02/201001/12/2023
5NDC:71335-0028-860 in 1 BOTTLE; Type 0: Not a Combination Product04/02/201001/12/2023
6NDC:71335-0028-515 in 1 BOTTLE; Type 0: Not a Combination Product04/02/201001/12/2023
7NDC:71335-0028-690 in 1 BOTTLE; Type 0: Not a Combination Product04/02/201001/12/2023
8NDC:71335-0028-9100 in 1 BOTTLE; Type 0: Not a Combination Product04/02/201001/12/2023
9NDC:71335-0028-37 in 1 BOTTLE; Type 0: Not a Combination Product04/02/201001/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07794612/27/200701/12/2023
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0028) , RELABEL(71335-0028)

Revised: 1/2023
 
Bryant Ranch Prepack