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Cetirizine Hydrochloride by Drug Ocean LLC

Medically reviewed on November 8, 2016

Dosage form: tablet
Ingredients: Cetirizine Hydrochloride 10mg
Labeler: Drug Ocean LLC
NDC Code: 70985-002

Cetirizine Hydrochloride Tablets USP 10 mg
Drug Facts

Active Ingredients

Active Ingredient (in each tablet)                                                                    Purpose
Cetirizine HCl USP 10 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
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 sever 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

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

DRUG OCEAN    NDC 70985-002-01

        Original Prescription Strength

Cetirizine Hydrochloride
Tablets USP

10 mg

6 yrs& older

100 Tablets

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
hypromelloses 
lactose 
magnesium stearate 
starch, corn 
polyethylene glycol 
povidone 
titanium dioxide 
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint CodeCTN;10
Contains    
Packaging
#Item CodePackage Description
1NDC:70985-002-01100 TABLET in 1 BOTTLE
2NDC:70985-002-02500 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(70985-002)

 
Drug Ocean LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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