INDOOR/OUTDOOR ALLERGY RELIEF SOFTGELS- cetirizine hydrochloride capsule

Indoor/Outdoor ALLERGY RELIEF Softgels by

Drug Labeling and Warnings

Indoor/Outdoor ALLERGY RELIEF Softgels by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

• 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 Symptom Relief

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

www.cvs.com   1-800-SHOP-CVS 

Package Label

 

CVS Pharmacy Indoor & Outdoor Allergy Relief

INGREDIENTS AND APPEARANCE

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

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 GLYCOL, UNSPECIFIED (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	03/01/2013	12/31/2020
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 59779-415-25	1 in 1 PACKAGE	03/01/2013	12/31/2020
2		25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 59779-415-40	1 in 1 PACKAGE	03/01/2013	12/31/2020
3		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022429	03/01/2013	12/31/2020

Labeler - CVS Pharmacy (062312574)