CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablets tablet, film coated 
REMEDYREPACK INC.

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Cetirizine Hydrochloride Tablets

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, 10mg

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

Ask a doctor before use if you have

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining 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

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

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.

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 a Poison Control Center right away.

Directions

adults and children 6 years and overone 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 between 20° to 25°C (68° to 77°F)

Inactive ingredients

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.

Questions?

call 1-888-375-

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

3784.

PRINCIPAL DISPLAY PANEL

DRUG: Cetirizine Hydrochloride

GENERIC: Cetirizine Hydrochloride Tablets

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-3468-0

NDC: 70518-3468-1

NDC: 70518-3468-2

NDC: 70518-3468-3

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 7 mm

IMPRINT: C

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 5 in 1 BOTTLE PLASTIC

PACKAGING: 7 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • CETIRIZINE HYDROCHLORIDE 10mg in 1

INACTIVE INGREDIENT(S):

  • HYPROMELLOSES
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL 400
  • POVIDONE
  • STARCH, CORN
  • TITANIUM DIOXIDE

Remedy_Label

MM2

MM3

MM4

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablets tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3468(NDC:43598-811)
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
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize7mm
FlavorImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-3468-030 in 1 BLISTER PACK; Type 0: Not a Combination Product08/09/202210/16/2023
2NDC:70518-3468-190 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/202210/16/2023
3NDC:70518-3468-25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/202210/16/2023
4NDC:70518-3468-37 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/202310/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07834308/09/202210/16/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 07d9fa69-c41a-700d-e063-6294a90a0253
Set id: 0ab350dd-52c0-46c9-888d-fe4187e8b5a4
Version: 6
Effective Time: 20231016
 
REMEDYREPACK INC.