INDOOR/OUTDOOR ALLERGY RELIEF SOFTGELS- cetirizine hydrochloride capsule 
CVS Pharmacy

----------

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:

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 reation 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

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 to the active ingredient in ZYRTEC®*

Original Prescription Strength

24 HOUR Symptom Relief

INDOOR & OUTDOOR ALLERGY RELIEF

CETIRIZINE HYDROCHLORIDE SOFTGELS 10 mg / ANTIHISTAMINE

24 hour relief of:

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 CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI  02895

www.cvs.com   1-800-SHOP-CVS 

Package Label

 Cetirizine HCl 10 mg

CVS Pharmacy Indoor & Outdoor Allergy Relief

INDOOR/OUTDOOR ALLERGY RELIEF SOFTGELS 
cetirizine hydrochloride capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-415
Route of Administration ORAL DEA Schedule     
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 7mm
Flavor Imprint Code CET
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-415-30 1 in 1 PACKAGE
1 30 in 1 BOTTLE, PLASTIC
2 NDC:59779-415-25 1 in 1 PACKAGE
2 25 in 1 BOTTLE, PLASTIC
3 NDC:59779-415-40 1 in 1 PACKAGE
3 40 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022429 03/01/2013
Labeler - CVS Pharmacy (062312574)

Revised: 8/2014
Document Id: 6645108a-3657-46eb-9c59-1d2ef8d13cc7
Set id: f1821981-ac9a-4589-8e53-85e79be5cf7c
Version: 3
Effective Time: 20140805
 
CVS Pharmacy