ALLERGY RELIEF- cetirizine hcl capsule 
Harmon Stores

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Drug Facts

Active ingredient (in each capsule)

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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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.

Directions

 adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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 at 20º-25°C (68º-77°F)
  • avoid high humidity and excessive heat above 40ºC (104ºF)
  • protect from light

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare Ours to the active ingredient in Zyrtec®*

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF

Cetirizine Hydrochloride Capsules, 10 mg

Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

SOFTGELS**

(**Liquid-filled capsules)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Zyrtec®.

Distributed by Harmon Stores, Inc.

Union, NJ 07083 USA

www.facevalues.com

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Cetirizine HCl 10 mg

Harmon Allergy Relief Softgels

ALLERGY RELIEF 
cetirizine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-211
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
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize7mm
FlavorImprint Code CET
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-211-251 in 1 BOX02/28/201512/31/2020
125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02242902/28/201512/31/2020
Labeler - Harmon Stores (804085293)

Revised: 11/2019
Document Id: 61d3814c-ce70-41fa-84ca-2152f7dbe2c8
Set id: 52266b53-7c12-4b14-ab1f-f03ab02b2bf7
Version: 3
Effective Time: 20191104
 
Harmon Stores