CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
REMEDYREPACK INC.

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OTC - ACTIVE INGREDIENT

(in each tablet)

Cetirizine HCl 5 mg

OTC - 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 reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

OTC - ASK DOCTOR

liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - ASK DOCTOR/PHARMACIST

before use if you are taking tranquilizers or sedatives.

OTC - WHEN USING

drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

OTC - STOP USE

if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING

if breast-feeding: not recommended if pregnant: ask a health professional before use.

OTC - 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 over1 to 2 tablets once daily; depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

STORAGE AND HANDLING

  •      Store between 20 to 25 C (68 to 77 F)

INACTIVE INGREDIENT

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

HOW SUPPLIED



Cetirizine Hydrochloride Tablets, USP 5 mg  are supplied as white to off-white,square tablets, debossed “APO 5mg” on obverse and plain on the reverse.

They are available as follows:

Bottles of 100:   NDC 60505-2632-1


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: CETIRIZINE HYDROCHLORIDE

GENERIC: CETIRIZINE HYDROCHLORIDE

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-088-02

STRENGTH:5 mg

COLOR: white

SHAPE: SQUARE

SCORE: No score

SIZE: 6 mm

IMPRINT: APO;5

QTY: 30

MM1



MM2

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49349-088
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorwhiteScoreno score
ShapeSQUARE (TABLET) Size6mm
FlavorImprint Code APO;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-088-0230 in 1 BLISTER PACK; Type 0: Not a Combination Product11/23/201011/24/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831711/23/201011/24/2010
Labeler - REMEDYREPACK INC. (829572556)

Revised: 9/2016
 
REMEDYREPACK INC.