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

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Cetrizine HCL Tablet 10 mg

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

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 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

  • 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 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

 adults and children 6 years and overTake 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
 consumers with liver or kidney disease ask a doctor

Other information

  • store between 20° and 25°C (68° - 77°F)

Inactive ingredients

Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.

Questions or comments?

1-800-645-2158

 *This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec®.  Zyrtec® is a registered trademark of UCB Pharma, S.A.

Distributed by:
 Rugby Laboratories
 31778 Enterprise Drive
 Livonia, MI  48150

www.rugbylaboratories.com

 Re-order No. 255553
 R-126
 Rev. 06/14

DRUG: Cetirizine Hydrochloride

GENERIC: Cetirizine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0910-0

NDC: 70518-0910-1

NDC: 70518-0910-2

COLOR: white

SHAPE: RECTANGLE

SCORE: No score

SIZE: 9 mm

IMPRINT: 10MG;APO

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • CETIRIZINE HYDROCHLORIDE 10mg in 1

INACTIVE INGREDIENT(S):

  • HYPROMELLOSES
  • POLYDEXTROSE
  • LACTOSE MONOHYDRATE
  • POLYETHYLENE GLYCOL 3350
  • CELLULOSE, MICROCRYSTALLINE
  • MAGNESIUM STEARATE
  • STARCH, CORN
  • TITANIUM DIOXIDE

Remedy_Label

MM2

MM3

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0910(NDC:0536-1041)
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code 10MG;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0910-030 in 1 BLISTER PACK; Type 0: Not a Combination Product12/14/201705/07/2020
2NDC:70518-0910-128 in 1 BLISTER PACK; Type 0: Not a Combination Product09/17/201805/07/2020
3NDC:70518-0910-230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/22/201805/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/14/201705/07/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2020
 
REMEDYREPACK INC.