Indoor/Outdoor ALLERGY RELIEF Softgels description, usages, side effects, indications, overdosage, supplying and lots more!

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Indoor/Outdoor ALLERGY RELIEF Softgels

CVS Pharmacy
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each capsule)

 Cetirizine HCl 10 mg

Purpose

 Antihistamine

Indoor/Outdoor ALLERGY RELIEF Softgels 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 reation to this product occurs. Seek medical help right away.

  • 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.

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
  • store between 20°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • 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 to the active ingredient in ZYRTEC®*

Original Prescription Strength

24 HOUR

NEW!

INDOOR/OUTDOOR ALLERGY RELIEF

CETIRIZINE HYDROCHLORIDE SOFTGELS 10 mg / ANTIHISTAMINE

24 hour relief of:

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • 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 CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI  02895

©2013 CVS/pharmacy

www.cvs.com   1-800-shop-CVS  V-30528

Package Label

Indoor/Outdoor ALLERGY RELIEF Softgels

CVS Pharmacy Indoor / Outdoor Allergy Relief
 

Indoor/Outdoor ALLERGY RELIEF Softgels

Cetirizine Hydrochloride CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-415
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 10 mg

Inactive Ingredients

Ingredient Name Strength
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
mannitol
POLYETHYLENE GLYCOLS
water
SODIUM HYDROXIDE
SORBITAN
sorbitol

Product Characteristics

Color Size Imprint Code Shape
YELLOW 7 mm CET CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, PLASTIC
2 25 in 1 BOTTLE, PLASTIC
3 NDC:59779-415-25 1 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022429 2013-03-01


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Be sure to consult your doctor before taking any medication!
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