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Cetirizine Hydrochloride by DIRECT RX

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: DIRECT RX
NDC Code: 61919-538

Cetirizine Hydrochloride

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)                                                        Purpose

Cetirizine HCl 10 mg..............................................................................................Antihistimine

OTC - PURPOSE SECTION

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 SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver 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 are taking tranquilizers or sedatives.

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

INDICATIONS & USAGE SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact Poison Control Center right away.

INSTRUCTIONS FOR USE SECTION
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 overAsk a doctor
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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

​OTC - QUESTIONS SECTION

Call 1-866-562-4597

SPL UNCLASSIFIED SECTION

Manufactured for PACK Pharmaceuticals, LLC

Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-538(NDC:16571-402)
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 GLYCOLS 
povidone 
titanium dioxide 
Product Characteristics
ColorwhiteScoreno score
ShapeBULLETSize8mm
FlavorImprint CodeCTN;10
Contains    
Packaging
#Item CodePackage Description
1NDC:61919-538-3030 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782901/01/2014
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIOperations
DIRECT RX079254320relabel(61919-538), repack(61919-538)

 
DIRECT RX

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Medically reviewed on Nov 9, 2018

Further information

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

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