CETIRIZINE HYDROCHLORIDE 10 MG- cetirizine hydrochloride tablet 
TWIN MED, LLC

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TWIN MED - PROCURE - CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG (55681-302)

Active ingredient (in each tablet)

Cetirizine Hydrochloride 10 mg

PURPOSE

ANTIHISTAMINE

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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:

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

If pregnant or breast-feeding:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

adults and children 6 years of age and over

One 10 mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms.

adults 65 years and older ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

call toll-free 1-800-935-6737

PDP

DF1

DF2

CETIRIZINE HYDROCHLORIDE  10 MG
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeRECTANGLE (ROUNDED) Size10mm
FlavorImprint Code G4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55681-302-03300 in 1 BOTTLE; Type 0: Not a Combination Product03/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927403/02/2022
Labeler - TWIN MED, LLC (009579330)

Revised: 1/2024
Document Id: 0e12b3c6-357a-b0dc-e063-6394a90a8ea4
Set id: d9437d88-da59-5567-e053-2995a90a362b
Version: 3
Effective Time: 20240103
 
TWIN MED, LLC