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CETIRIZINE HYDROCHLORIDE by Northstar Rx LLC

Medically reviewed on July 25, 2017

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Northstar Rx LLC
NDC Code: 16714-271

Active ingredient (in each tablet)

Cetirizine Hydrochloride USP, 10 mg

Purpose

Antihistamine

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 reaction 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 overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

store between 20° to 25°C (68° to 77°F).

Inactive ingredients

corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide

Questions or comments?

call toll free 1-800-206-7821

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16714-271-02

Cetirizine Hydrochloride Tablets, USP 10 mg

Antihistamine

Allergy

6 Years and Older

24 Hour Relief of:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

NORTHSTARTM

100 Tablets 10 mg Each

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16714-271
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
POVIDONE K29/32 
MAGNESIUM STEARATE 
Product Characteristics
Colorwhite (white to off-white) Scoreno score
Shapecapsule (rounded off rectangular) Size9mm
FlavorImprint CodeS;521
Contains    
Packaging
#Item CodePackage Description
1NDC:16714-271-02100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:16714-271-03300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07886210/19/2009
Labeler - Northstar Rx LLC (830546433)
Registrant - Orchid Pharma Ltd. (650133507)
Establishment
NameAddressID/FEIOperations
Orchid Healthcare (A Division of Orchid Pharma Ltd.)650288850manufacture(16714-271), analysis(16714-271), pack(16714-271), label(16714-271)

 
Northstar Rx LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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