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Cetirizine Hydrochloride by A-S Medication Solutions

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: A-S Medication Solutions
NDC Code: 50090-1089

Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

ACTIVE INGREDIENTS

Active Ingredients (in each tablet)                                                Purpose

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

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
  • 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

Stop use and ask a doctor if an allergic reaction tothis 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.

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 severe symptoms.
Adults 65 years and overAsk a doctor
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor

OTHER INFORMATION

store at 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 by:

Unique Pharmaceutical Labs.

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


Distributed by:

Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663

 

M. L. G/1430    May 2018

 

120005


Cetirizine Hydrochloride
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1089(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
HYPROMELLOSE, UNSPECIFIED 
LACTOSE, UNSPECIFIED FORM 
magnesium stearate 
starch, corn 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
titanium dioxide 
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint CodeCTN;10
Contains    
Packaging
#Item CodePackage Description
1NDC:50090-1089-014 TABLET in 1 BOTTLE
2NDC:50090-1089-130 TABLET in 1 BOTTLE
3NDC:50090-1089-2100 TABLET in 1 BOTTLE
4NDC:50090-1089-390 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-1089), REPACK(50090-1089)

 
A-S Medication Solutions

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Medically reviewed on Aug 28, 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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