CURIST ALLERGY RELIEF- cetirizine hydrochloride tablet, coated

Curist Allergy Relief by

Drug Labeling and Warnings

Curist Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Little Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTHER SAFETY INFORMATION

Important: Read the directions and warnings before use. Keep the carton, it contains important information.

Do not use if imprinted foil inner seal on bottle is broken or missing.

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

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

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

• store between 20° to 25°C (68° to 77°F)
• contains no ingredient from a gluten-containing grain (Wheat, barley, rye)

INACTIVE INGREDIENT

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

QUESTIONS

Questions? Call 1-877-770-3183

Weekdays 9:00 AM to 4:30 PM EST

SPL UNCLASSIFIED SECTION

Distributed by:

Little Pharma, Inc. New York, NY 10023

Made in India

PRINCIPAL DISPLAY PANEL

curist

Allergy Relief

Cetirizine Hydrochloride Tablets, USP 10 mg

Antihistamine

24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat

30 Tablets

INGREDIENTS AND APPEARANCE

CURIST ALLERGY RELIEF 
cetirizine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72559-003
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white (white to off white)	Score	2 pieces
Shape	RECTANGLE (rounded off rectangular)	Size	9mm
Flavor		Imprint Code	G;4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72559-003-02	1 in 1 CARTON	06/26/2019
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209274	06/26/2019

Labeler - Little Pharma, Inc. (074328189)