ALLERGY RELIEF- cetirizine hcl 10 mg tablet

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Genomma Labs USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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 doctor if you have

• liver or kidney disease. Your doctor should determine if you need a different dose.

Ask doctor or pharmacist before use if youare

taking sedatives or tranquilizers

When using this product

• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when drivinga motor vehicle or operating machinery

Stop use and ask 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• Adults and children 6 years and older:  One 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg 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°C to 25°C (68°F to 77°F )
• do not use if carton is opened or if blister unit is torn, broken or showing any signs of tampering

Inactive Ingredients

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, starch, titanium dioxide

Questions or comments

Call toll free 1 877 99 GENOM (4366). Monday to Friday from 8 am to 6 pm

Manufactured for

A&Z Pharmaceutical, Inc.
Hauppauge, NY 11788

Package/Label Principal Display Panel

Next Allergy

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
cetirizine hcl 10 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-310
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	RECTANGLE (pillow-shaped)	Size	9mm
Flavor		Imprint Code	10MG;APO
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-310-09	1 in 1 CARTON	12/16/2014
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50066-310-45	3 in 1 CARTON	12/16/2014
2		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078317	12/16/2014

Labeler - Genomma Labs USA, Inc (832323534)