CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
TriMarc Labs

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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

68752005 label



CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68752-005(NDC:0904-6100)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code RB80;
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68752-005-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/03/201001/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749806/25/201001/10/2019
Labeler - TriMarc Labs (156893695)
Registrant - TriMarc Labs (156893695)
Establishment
NameAddressID/FEIBusiness Operations
TriMarc Labs156893695repack(68752-005)

Revised: 1/2019
 
TriMarc Labs