Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
REMEDYREPACK INC.

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Drug Facts

Active ingredient

(in each tablet)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Keep Out of Reach of Children

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

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.

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 over:

  1 to 2 tablets once daily; depending upon severity of symptoms; do not take more than 2 tablets in 24 hours

• adults 65 years and over:

  1 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

Other information

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

Inactive ingredients

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

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.06/2013

PRINCIPAL DISPLAY PANEL

DRUG: Cetirizine Hydrochloride

GENERIC: Cetirizine Hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0777-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: SZ;905

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• CETIRIZINE HYDROCHLORIDE 5mg in 1

INACTIVE INGREDIENT(S):

• MAGNESIUM STEARATE
• POVIDONES
• TITANIUM DIOXIDE
• POLYETHYLENE GLYCOLS
• HYPROMELLOSES
• LACTOSE MONOHYDRATE
• STARCH, CORN

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0777(NDC: 0781-1683)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND (round shape)	Size	6mm
Flavor		Imprint Code	SZ;905
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0777-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/10/2017	10/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077946	10/10/2017	10/20/2017

Labeler - REMEDYREPACK INC. (829572556)

Revised: 7/2019

Document Id: 8ec6cb2a-0873-6814-e053-2995a90a66d0

34390-5

Set id: 00ae9541-2bd6-4248-aa32-36d2829cf735

Version: 2

Effective Time: 20190728