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Allergy Relief by Allegiant Health

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Allegiant Health
NDC Code: 69168-310

Drug Facts

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 useif 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 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 Ask a doctor
disease

Other information
 
store between 20°C to 25°C (68°F to 77°F )
 
do not use if safety seal under cap is open or missing

Inactive Ingredients

hypromellose*, lactose monohydrate, magnesium stearate, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl glycol*, povidone*, starch, talc* and titanium dioxide. *May also contain.

Questions or comments

Call toll free 1-888-952-0050

Manufactured for

A&Z Pharmaceutical, Inc.
Hauppauge, NY 11788

Package/Label Principal Display Panel

Allergy relief

Cetirizine 10 mg/ Antihistamine

Indoor & Outdoor Allergies

24 hourRelief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

ALLERGY RELIEF 
cetirizine hcl 10 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-310(NDC:60505-2633)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONES 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code10MG;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-310-0910 TABLET in 1 BLISTER PACK
2NDC:69168-310-3030 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/16/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-310), LABEL(69168-310), PACK(69168-310), RELABEL(69168-310), REPACK(69168-310)

 
Allegiant Health

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Medically reviewed on Dec 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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