CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated 
Northstar Rx LLC

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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

image description

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16714-271
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)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POVIDONE K29/32 (UNII: 390RMW2PEQ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
Shapecapsule (rounded off rectangular) Size9mm
FlavorImprint Code S;521
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16714-271-02100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/200908/31/2021
2NDC:16714-271-03300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/200908/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07886210/19/200908/31/2021
Labeler - Northstar Rx LLC (830546433)
Registrant - Orchid Pharma Ltd. (650133507)
Establishment
NameAddressID/FEIBusiness Operations
Orchid Healthcare (A Division of Orchid Pharma Ltd.)650288850manufacture(16714-271) , analysis(16714-271) , pack(16714-271) , label(16714-271)

Revised: 11/2020
Document Id: 8807545d-1d6b-4360-b7ad-30bf2321766a
Set id: d2166bf5-41a2-4592-8428-818f0dad402d
Version: 11
Effective Time: 20201116
 
Northstar Rx LLC