CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
REMEDYREPACK INC.

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Perrigo Cetirizine Hydrochloride Tablets 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:

  1. runny nose
  2. sneezing
  3. itchy, watery eyes
  4. 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

  1. drowsiness may occur
  2. avoid alcoholic drinks
  3. alcohol, sedatives, and tranquilizers may increase drowsiness
  4. 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:

  1. if breast-feeding: not recommended
  2. 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. (1-800-222-1222)

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

consumers with liver or kidney disease

ask a doctor

Other information

  1. store between 20 - 25°C (68 - 77°F)
  2. do not use if printed foil under cap is broken or missing

Inactive ingredients

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

DRUG: cetirizine hydrochloride

GENERIC: Cetirizine Hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-373-19

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 10 mm

IMPRINT: 4H2

PACKAGING: 90 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • CETIRIZINE HYDROCHLORIDE 10mg in 1

INACTIVE INGREDIENT(S):

  • FD&C BLUE NO. 1
  • POVIDONES
  • POLYETHYLENE GLYCOLS
  • TITANIUM DIOXIDE
  • TRIACETIN
  • HYPROMELLOSES
  • LACTOSE MONOHYDRATE
  • POLYDEXTROSE
  • MAGNESIUM STEARATE
  • STARCH, CORN

Remedy_Label

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49349-373(NDC:45802-919)
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)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize10mm
FlavorImprint Code 4H2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-373-1990 in 1 BOTTLE; Type 0: Not a Combination Product10/23/201312/12/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833610/23/201312/12/2014
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2016
Document Id: 3fb50a9b-14e0-60c8-e054-00144ff8d46c
Set id: c3f55902-ba7c-4d54-a7ad-e25cc995e247
Version: 2
Effective Time: 20161025
 
REMEDYREPACK INC.