Cetirizine hydrochloride (allergy) tablet

Spl unclassified section

Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)


Drug Facts

Active ingredient (in each tablet)

Cetirizine hydrochlorideUSP 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 useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Otc - ask doctor section

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking 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. [1-800-222-1222]

Directions


adults and children
6 years and over
one 10 mgtablet once daily;
do not take more than one 10 mg
tabletin 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

  • storebetween 20 to 25C (68 to 77F)
  • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

call 1-800-206-7821

Manufactured for: Northstar Rx LLC

Memphis, TN 38141

Manufactured by: Aurobindo Pharma Limited

Hyderabad-500 090, India

Code: TS/DRUGS/19/1993

Issued: 03/2018

Ingredients and appearance - Product information

Cetirizine hydrochloride (allergy) tablet- Cetirizine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 16714-799
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cetirizine hydrochloride ( UNII: 64O047KTOA)( Cetirizine - UNII: YO7261ME24 ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromellose 2910 (5 mpa.s) ( UNII: R75537T0T4)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE (White to Off-white) Shape ROUND
Size 8 mm Score 1
Imprint Code X;36

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 16714-799-01 30 in 1 BOTTLE 2015/08/05
2 NDC: 16714-799-02 100 in 1 BOTTLE 2015/08/05
3 NDC: 16714-799-03 300 in 1 BOTTLE 2015/08/05
4 NDC: 16714-799-04 500 in 1 BOTTLE 2015/08/05

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090760 USA 2015/08/05

Labeler - NorthStar Rx LLC( 830546433)

Establishment

Name ID/FEI Business Operations
NorthStar Rx LLC 830546433 ANALYSIS( 16714-799), MANUFACTURE( 16714-799)

Package label-principal display panel -10 mg (500'stablets container label)

NDC 16714-799-04
Cetirizine Hydrochloride
Tablets USP 10 mg
Antihistamine
ALLERGY RELIEF
Original Prescription Strength

Indoor & Outdoor Allergies
24 Hour Relief of :

Sneezing Runny Nose

Itchy, Watery Eyes Itchy Throat or Nose

500 Tablets

10 mg each