Safeway Inc. 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 blister unit is broken or torn (Blister Only)
•: do not use if printed foil under cap is broken or missing (Bottle Only)
•: store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

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Principal Display Panel

24 HOUR – ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

Cetirizine Hydrochloride Tablets 10 mg

Antihistamine

Compare to Zyrtec® active ingredient

Indoor & outdoor allergies

24 Hour relief of:

sneezing, runny nose; itchy, watery eyes; itchy throat or nose

Actual Size

14 TABLETS

ALLERGY RELIEF 24 HOUR
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21130-458
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21130-458-66	14 in 1 CARTON	02/15/2008	05/01/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:21130-458-39	1 in 1 CARTON	02/15/2008	05/01/2017
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:21130-458-95	1 in 1 CARTON	02/15/2008	05/01/2017
3		45 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:21130-458-76	1 in 1 CARTON	02/15/2008	05/01/2017
4		120 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:21130-458-88	1 in 1 CARTON	02/15/2008	05/01/2017
5		365 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	ANDA078336	02/15/2008	05/01/2017

Labeler - Safeway (009137209)

Revised: 11/2017

Document Id: 1040baf8-813e-46c8-8279-575340726feb

Set id: fe1c3dfa-0a1c-4448-8efc-b52e1e08d4a3

Version: 5

Effective Time: 20171118

Safeway