CAREONE ALLERGY RELIEF- cetirizine hydrochloride tablet, film coated 
American Sales Company

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American Sales Company 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

store between 20-25°C (68-77°F)
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

Principal Display Panel

Compare to the active ingredient in Zyrtec®

24hr

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

Cetirizine Hydrochloride Tablets, 10mg

Antihistamine

Actual Size

70 TABLETS

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing – Runny Nose

Itchy, Watery Eyes – Itchy Throat Or Nose

OUR PHARMACISTS RECOMMEND

allergy relief image
CAREONE ALLERGY RELIEF 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-781
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize10mm
FlavorImprint Code 4H2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-781-6614 in 1 CARTON09/29/2016
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41520-781-061 in 1 CARTON09/29/2016
270 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:41520-781-391 in 1 CARTON09/29/2016
330 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:41520-781-751 in 1 CARTON09/29/2016
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:41520-781-951 in 1 CARTON09/29/2016
545 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:41520-781-761 in 1 CARTON04/12/2019
6120 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:41520-781-581 in 1 CARTON10/29/2019
740 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833609/29/2016
Labeler - American Sales Company (809183973)

Revised: 10/2019
Document Id: 0fafab9b-e0ba-4012-afa8-67e566e8509c
Set id: 533abfc1-226e-4a68-bfcc-ec046a4d5751
Version: 4
Effective Time: 20191029
 
American Sales Company