Cetirizine Hydrochloride Tablets

Drug Labeling and Warnings

Drug Details [pdf]

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Major Pharmaceuticals

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Cetirizine Hydrochloride Tablets

Active ingredient

Active ingredient: Cetirizine Hcl 10 mg.......Antihistamine

Purpose

Purpose: Antihistamine

Use

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.

Warning

Warnings: Do not use if you have ever had an allergic reaction to this product or any of it's ingredients or to an antihistamine containing hydroxyzine.

For external use only

Do not use

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

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

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.

Pregnancy/breast-feeding warning

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 poison control center right away. (1-800-222-1222).

Directions

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

Consumer with liver or kidney disease:    Ask a doctor

Other information

Store at controlled room temperature 15 and 30 degrees C (59-86 degrees F).

Inactive ingredients

Inactive Ingredients: Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide.

Questions?

To report adverse drug event call: (800) 616-2471

PRINCIPAL DISPLAY PANEL

Cetirizine Hcl 10 mg Tabs

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	RB80;
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6100-61	100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	06/25/2010	06/30/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077498	06/25/2010	06/30/2015

Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2019

Document Id: 98bb2a7b-33f7-4260-a6d0-7153b40c5212

34390-5

Set id: c6c8afb8-665b-4cac-ac1d-c750d804f916

Version: 5

Effective Time: 20190827