Rite Aid 44-578-delisted

Drug Details [pdf]

CHILDRENS ALLERGY RELIEF- cetirizine hcl tablet, chewable
Rite Aid Corporation

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Rite Aid 44-578-delisted

Active ingredient (in each chewable tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
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
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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 (1-800-222-1222) right away.

Directions

may be taken with or without water

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

see end flap for expiration date and lot number
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store between 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc, tutti frutti flavor

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

RITE
AID®
PHARMACY

*Compare to the active ingredient
in Children's Zyrtec® Allergy

ORIGINAL PRESCRIPTION
STRENGTH

children's
allergy relief

cetirizine HCl tablets, 10 mg
antihistamine

INDOOR &
OUTDOOR ALLERGIES

tutti-frutti flavor

24 hour relief of:
sneezing
runny nose
itchy, watery eyes
itchy throat or nose

6 years
& older

ACTUAL
SIZE

12 CHEWABLE
TABLETS

TAMPER EVIDENT: DO
NOT USE IF PACKAGE
IS OPENED OR IF
BLISTER UNIT IS
TORN, BROKEN OR
SHOWS ANY SIGNS
OF TAMPERING

*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the
registered trademark Children's Zyrtec® Allergy.
50844 ORG031357802

DISTRIBUTED BY: RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011

PRODUCT OF INDIA

IF YOU'RE NOT
SATISFIED, WE'LL
HAPPILY REFUND
YOUR MONEY.

Rite Aid 44-578

CHILDRENS ALLERGY RELIEF
cetirizine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0578
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BETADEX (UNII: JV039JZZ3A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PINK (peach color)	Score	no score
Shape	ROUND	Size	10mm
Flavor	TUTTI FRUTTI	Imprint Code	SZ;106
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 11822-0578-2	2 in 1 CARTON	10/31/2008	07/19/2019
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078692	10/31/2008	07/19/2019

Labeler - Rite Aid Corporation (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(11822-0578)

Revised: 7/2019

Document Id: 2b85af84-8682-4adb-8d66-4cd170d39659

Set id: 1b583726-7f19-4663-a479-8fca9387fade

Version: 8

Effective Time: 20190719