Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

k">

ALLERGY RELIEF- cetirizine hcl 10 mg tablet 
Allegiant Health

----------

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 pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

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 safety seal under cap is open or missing
  • do not use if blister unit is broken or torn 

Inactive Ingredients

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

Questions or comments?

Call toll free 1-888-952-0050

Manufactured for

A&Z Pharmaceutical, Inc.
Hauppauge, NY 11788

Package/Label Principal Display Panel

Cetirizine HCl 10mg

Cetirizine HCl 10mg

ALLERGY RELIEF 
cetirizine hcl 10 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69168-310
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
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
ColorWHITEScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code 10MG;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69168-310-0910 in 1 BLISTER PACK; Type 0: Not a Combination Product12/16/2014
2NDC: 69168-310-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/16/2014
Labeler - Allegiant Health (079501930)

Revised: 11/2018
 
Allegiant Health


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.