ALLERGY RELIEF- cetirizine hydrochloride tablet
Shopko Stores Operating Co., LLC

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Shopko Allergy Relief Drug Facts

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:

•: 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 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. (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

•: do not use if printed foil under cap is broken or missing
•: store between 20° to 25°C (68° to 77°F)

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

Principal Display Panel

Compare to Zyrtec® active ingredient

Original Prescription Strength

Allergy Relief

Cetirizine Hydrochloride Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat or Nose

24 HOUR SYMPTOM RELIEF

Actual Size

30 Tablets

ALLERGY RELIEF
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:37012-458
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (CETIRIZINE)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN
FD&C BLUE NO. 1
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POVIDONES
TITANIUM DIOXIDE
TRIACETIN

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

#	Item Code	Package Description
Packaging
1	NDC:37012-458-39	1 in 1 CARTON
1		30 in 1 BOTTLE
2	NDC:37012-458-66	1 in 1 CARTON
2		14 in 1 BLISTER PACK
3	NDC:37012-458-72	1 in 1 CARTON
3		60 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078336	07/08/2013

Labeler - Shopko Stores Operating Co., LLC (023252638)

Revised: 8/2013

Document Id: 2a6c7436-0ac3-4bc3-88d8-4b7fc614b63b

Set id: 2a6c7436-0ac3-4bc3-88d8-4b7fc614b63b

Version: 1

Effective Time: 20130823

Shopko Stores Operating Co., LLC