Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, 10mg

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 antihistaminecontaining 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	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° to 25°C (68° to 77°F)

Inactive ingredients

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.

Questions?

call 1-888-375-3784.

PRINCIPAL DISPLAY PANEL

300 ct Carton

Carton

Principal Display Panel

300 ct Container label

Bottle Label

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablets tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-1007
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	C
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-1007-3	1 in 1 CARTON	05/05/2023
1		90 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:70677-1007-1	1 in 1 CARTON	05/05/2023
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:70677-1007-2	1 in 1 CARTON	05/05/2023
3		60 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:70677-1007-4	1 in 1 CARTON	05/05/2023
4		300 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078343	05/12/2022

Labeler - Strategic Sourcing Services LLC (116956644)

Cetirizine Hydrochloride Tablets