CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet

Cetirizine Hydrochloride (Allergy) by

Drug Labeling and Warnings

Cetirizine Hydrochloride (Allergy) by is a Otc medication manufactured, distributed, or labeled by NorthStar Rx LLC, Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)

 
Drug Facts

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 DOCTOR

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

ASK DOCTOR/PHARMACIST

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. [1-800-222-1222]

Directions

• adults and children6 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 orkidney disease: ask a doctor

Other information

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (500's Tablets 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

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16714-799
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	X;36
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16714-799-01	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
2	NDC: 16714-799-02	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
3	NDC: 16714-799-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
4	NDC: 16714-799-04	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090760	08/05/2015

Labeler - NorthStar Rx LLC (830546433)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917642	ANALYSIS(16714-799) , MANUFACTURE(16714-799)