CETIRIZINE- cetirizine hydrochloride tablet, film coated 
Major Pharmaceuticals

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Major Pharmaceuticals Cetirizine 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?

1-800-616-2471

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MAJOR®

Compare to active ingredient in Zyrtec®

Original Prescription Strength

Cetirizine

Hydrochloride Tablets, 10 mg/Antihistamine

All Day Allergy Relief

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Actual Size

30 TABLETS 10 mg EACH

all day allergy relief

CETIRIZINE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6717
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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (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:0904-6717-4114 in 1 CARTON06/29/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0904-6717-431 in 1 CARTON07/03/2018
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0904-6717-40500 in 1 BOTTLE; Type 0: Not a Combination Product07/03/2018
4NDC:0904-6717-721 in 1 CARTON07/03/2018
4300 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0904-6717-601 in 1 CARTON07/03/2018
5100 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0904-6717-861 in 1 CARTON07/03/2018
690 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0904-6717-461 in 1 CARTON07/03/2018
730 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833606/29/2018
Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2022
Document Id: 961f9ea8-4fe5-4e14-a638-e7a5b1df236b
Set id: a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3
Version: 4
Effective Time: 20221110
 
Major Pharmaceuticals