CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Drug Ocean LLC

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Cetirizine Hydrochloride Tablets USP , 5 mg

Drug Facts

Active Ingredients

Active Ingredient (in each tablet)                                                        Purpose
Cetirizine HCl USP 5 mg.....................................................................................Antihistimine

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)

Directions

Adults and children 6
 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
Adults 65 years and over1 tablet1 tablet once a day; do not take more than 1 tablet in 24 hours.
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) [See USP Controlled Room Temperature.]

Inactive Ingredients

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Questions?

Call 1-866-562-4597

Manufactured for:

Drug Ocean, LLC
1 Bridge Plaza, North Central Road,

6th Floor, Suite 675,

Fort Lee, NJ 07024

Manufactured by:

Unique Pharmaceutical Laboratories
(A Div. of J. B. Chemicals &Pharmaceuticals Ltd.),
Mumbai 400 030, India

M.L. G/1430

Rev. 12/2023

Cetirizine Hydrochloride Tablets 5 mg Container Label

DRUG OCEAN NDC 70985-001-01

Original Prescription Strength

Cetirizine Hydrochloride

Tablets USP

5 mg

100 Tablets

100 tablets

DRUG OCEAN NDC 70985-001-02

Original Prescription Strength

Cetirizine Hydrochloride

Tablets USP

5 mg

500 Tablets

500 tablets

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint Code CTN;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70985-001-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2016
2NDC:70985-001-02500 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782911/08/2016
Labeler - Drug Ocean LLC (080381835)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645manufacture(70985-001)

Revised: 12/2023
Document Id: 0d2e2348-8d39-1ca9-e063-6394a90a881f
Set id: da7b0ec8-fd3b-4b07-b196-edbc72a53b3f
Version: 5
Effective Time: 20231223
 
Drug Ocean LLC