Your browser does not support JavaScript! ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [CARDINAL HEALTH (LEADER) 37205]
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ALL DAY ALLERGY (cetirizine hcl) capsule
[Cardinal Health (Leader) 37205]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

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 overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

  • store between 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 1-800-200-6313 Monday through Friday 9AM - 5PM EST.

Principal Display Panel

Compare to Zyrtec® active ingredient†

All Day Allergy

Cetirizine HCl 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®.

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

KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: CARDINAL HEALTH

DUBLIN, OH  43017

www.myleader.com

Package Labeling

Cetirizine HCl 10 mg

Leader All Day Allergy Softgel

ALL DAY ALLERGY 
cetirizine hcl capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-819
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
MANNITOL 
POLYETHYLENE GLYCOLS 
WATER 
SODIUM HYDROXIDE 
SORBITAN 
SORBITOL 
FD&C YELLOW NO. 6 
GELATIN 
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize13mm
FlavorImprint Code CET
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-819-631 in 1 PACKAGE
125 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02242903/03/2013
Labeler - Cardinal Health (Leader) 37205 (097537435)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 3/2013
 
Cardinal Health (Leader) 37205

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