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Cetirizine hydrochloride by TriMarc Labs

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: TriMarc Labs
NDC Code: 68752-005

Cetirizine Hydrochloride Tablets

Active ingredient

Active ingredient: (in each tablet)

Cetirizine Hcl 10 mg.......Antihistamine

Purpose

Purpose: Antihistamine

Use

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.

Warning

Warnings: Do not use if you have ever had an allergic reaction to this product or any of it's ingredients or to an antihistamine containing hydroxyzine.

For external use only

Do not use


Ask a doctor before use if you have

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

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

When using this product

         When using this product

  • drowsiness may occur.
  • Avoid alcoholic drinks.
  • Alcohol, sedatives and tranquilizers may increase drowsiness.
  • Be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

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

Pregnancy/breast-feeding warning

            If pregnant or breast-feeding:

  • If breast feeding, not recommended.
  • If pregnant- ask a health professional before use.

Keep out of reach of children

            Keep out of reach of children.

  • In case of overdose, get medical help or contact poison control center right away.

Directions

         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 over:    Ask a doctor
  • Children under 6 years of age:    Ask a doctor
  • Consumer with liver or kidney disease:    Ask a doctor

Other information

         Other information

  • Store between 20 and 25 degrees C (68-77 degrees F).

           TAMPER EVIDENT: DO NOT USE IF EAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

Inactive Ingredients: Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide.

Questions?

To report adverse drug event call: (800) 616-2471

PRINCIPAL DISPLAY PANEL





CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68752-005(NDC:0904-6100)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POVIDONE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeRB80;
Contains    
Packaging
#Item CodePackage Description
1NDC:68752-005-9090 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749806/25/2010
Labeler - TriMarc Labs (156893695)
Registrant - TriMarc Labs (156893695)
Establishment
NameAddressID/FEIOperations
TriMarc Labs156893695repack(68752-005)

Revised: 10/2017
 
TriMarc Labs

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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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