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

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Compare to Zyrtec® active ingredient

Cetirizine Hydrochloride Tablets 10 mg

Antihistamine

Allergy

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Original Prescription Strength

actual size

30 Tablets

Indoor & Outdoor Allergies

NDC 71205-207-30

Repackaged By:

Proficient Rx LP

Thousand Oaks, CA 91320

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-207(NDC:45802-919)
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
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	4H2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-207-06	6 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2019
2	NDC:71205-207-10	10 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2019
3	NDC:71205-207-15	15 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2019
4	NDC:71205-207-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
5	NDC:71205-207-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
6	NDC:71205-207-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078336	12/27/2007

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-207) , RELABEL(71205-207)

Perrigo Cetirizine Hydrochloride Tablets 10 mg Drug Facts