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Cetirizine Hydrochloride by Drug Ocean LLC

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Drug Ocean LLC
NDC Code: 70985-001

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
  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

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 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
221 River street, Suite 9063,
Hoboken, NJ 07030

Manufactured by:

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

M.L. G/1430

Rev. 11-2016

Cetirizine Hydrochloride Tablets 5 mg Container Label

DRUG OCEAN    NDC 70985-001-01

        Original Prescription Strength

Cetirizine Hydrochloride
Tablets USP

5 mg

100 Tablets

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
STARCH, CORN 
POLYETHYLENE GLYCOLS 
POVIDONE 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint CodeCTN;5
Contains    
Packaging
#Item CodePackage Description
1NDC:70985-001-01100 TABLET in 1 BOTTLE
2NDC:70985-001-02500 TABLET in 1 BOTTLE
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/FEIOperations
Unique Pharmaceutical Laboratories650434645MANUFACTURE(70985-001)

Revised: 11/2016
 
Drug Ocean LLC

← See all Cetirizine Hydrochloride brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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