CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated
STRATEGIC SOURCING SERVICES LLC

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Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl USP, 10 mg

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 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 reation 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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
store between 20° to 25°C (68° to 77°F).

Inactive ingredients

corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white.

The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide.

Questions ?

call 1-866-562-4590

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton: 30 Tablets

Sunmark

Compare to the active ingredient in Zyrtec® Allergy*

NDC 49348-939-44

cetirizine HCl tablets USP, 10 mg

Antihistamine

Allergy

6 Years and Older

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE

Indoor & Outdoor Allergies

24 hour relief of: sneezing; runny nose;

itchy, watery eyes; itchy throat or nose

ORIGINAL PRESCRIPTION STRENGTH

30 TABLETS 10 mg EACH

carton30

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-939
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)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POVIDONE K29/32 (UNII: 390RMW2PEQ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	CAPSULE (Rounded-off; Rectangular)	Size	9mm
Flavor		Imprint Code	S;521
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49348-939-44	1 in 1 CARTON	08/01/2011	03/31/2018
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:49348-939-12	1 in 1 CARTON	08/01/2011	03/31/2018
2		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078862	08/01/2011	03/31/2018

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - Orchid Pharma Ltd. (650133507)

Name	Address	ID/FEI	Business Operations
Establishment
Orchid Healthcare		650288850	analysis(49348-939) , manufacture(49348-939) , pack(49348-939) , label(49348-939)

Revised: 9/2019

Document Id: 37c5d522-31ce-4e34-a0ff-c3c8adc0f1d4

Set id: 029640e5-aaa0-4748-8c2a-b7aaff40d894

Version: 8

Effective Time: 20190903

STRATEGIC SOURCING SERVICES LLC