Allergy Relief
Cetirizine Hydrochloride Tablets
ae4b478a-452a-464d-9e6e-5bb987d98bd4
HUMAN OTC DRUG LABEL
Jul 30, 2025
CVS Pharmacy
DUNS: 062312574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cetirizine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Label
CVS HEALTH Allergy Relief
INDICATIONS & USAGE SECTION
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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
OTC - PURPOSE SECTION
Purpose
Antihistamine
STORAGE AND HANDLING SECTION
Other Information
- store at 20ºto 25oC (68o to 77o F)
- avoid high humidity and excessive heat above 40o C (104o F)
- protect from light
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Butylated hydroxytolene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, Sorbitan, Sorbitol
OTC - STOP USE SECTION
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each capsule)
Cetirizine HCl 10 mg
WARNINGS SECTION
Warning
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking tranquilizers or sedatives.
OTC - WHEN USING SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
DOSAGE & ADMINISTRATION SECTION
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 |
SPL UNCLASSIFIED SECTION
Principal Display Panel
Compare to the active ingredient in ZYRTEC®*
Indoor & Outdoor Allergies
Original Prescription Strength
Allergy Relief
CETIRIZINE HYDROCHLORIDE CAPSULES, 10 mg
Antihistamine
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, distributor of Zyrtec®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
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