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Cetirizine Hydrochloride by Bryant Ranch Prepack

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Bryant Ranch Prepack
NDC Code: 71335-0028

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: 71335-0028-4 10 TABLET in a BOTTLE

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

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

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

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

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

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

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

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

Cetirizine Hcl 10mg Tablet
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0028(NDC:0781-1684)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONE, UNSPECIFIED 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (round shape) Size8mm
FlavorImprint CodeSZ;906
Contains    
Packaging
#Item CodePackage Description
1NDC:71335-0028-410 TABLET in 1 BOTTLE
2NDC:71335-0028-720 TABLET in 1 BOTTLE
3NDC:71335-0028-130 TABLET in 1 BOTTLE
4NDC:71335-0028-214 TABLET in 1 BOTTLE
5NDC:71335-0028-860 TABLET in 1 BOTTLE
6NDC:71335-0028-515 TABLET in 1 BOTTLE
7NDC:71335-0028-690 TABLET in 1 BOTTLE
8NDC:71335-0028-9100 TABLET in 1 BOTTLE
9NDC:71335-0028-37 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07794612/27/2007
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(71335-0028), RELABEL(71335-0028)

Revised: 12/2017
 
Bryant Ranch Prepack

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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