CETIRIZINE- cetirizine hydrochloride tablet, film coated

Cetirizine by

Drug Labeling and Warnings

Cetirizine by is a Otc medication manufactured, distributed, or labeled by Northwind Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Principal Display Panel

NDC: 51655-194-26

INGREDIENTS AND APPEARANCE

CETIRIZINE 
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51655-194(NDC:0904-6717)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	4H2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51655-194-60	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/18/2022
2	NDC: 51655-194-26	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/15/2022
3	NDC: 51655-194-52	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078336	10/18/2022

Labeler - Northwind Pharmaceuticals, LLC (036986393)

Registrant - Northwind Pharmaceuticals, LLC (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmaceuticals, LLC		036986393	repack(51655-194)