Drug Facts
04b08c52-5390-4cdb-a9e7-fca81fffdc73
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Cetirizine HCl 5 mg Cetirizine HCl 10 mg
Medication Information
Warnings and Precautions
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine
Ask a doctor before useif 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
-
•avoid alcoholic drinks
-
•alcohol, sedatives, and tranquilizers may increase drowsiness
-
•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.
Indications and Usage
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
Dosage and Administration
Cetirizine Hydrochloride Tablets, USP 5 mg
|
adults and children 6 years and over |
1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours. |
|
adults 65 years and over |
1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours. |
|
children under 6 years of age |
ask a doctor |
|
consumers with liver or kidney disease |
ask a doctor |
Cetirizine Hydrochloride Tablets, USP 10 mg
|
adults and children 6 years and over |
one 10 mg tablet once daily; do not take more than one 10 mg tablet 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 |
Description
Cetirizine HCl 5 mg Cetirizine HCl 10 mg
Section 51727-6
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Section 55105-1
Antihistamine
Section 55106-9
Cetirizine HCl 5 mg
Cetirizine HCl 10 mg
Section 60561-8
Questions or comments?
call toll-free weekdays 9 AM to 5 PM EST at 1 (888) 721-7115
Manufactured by:
Glenmark Pharmaceuticals Limited
Pithampur, Madhya Pradesh 454775, India
Distributed by:
Glenmark Therapeutics Inc., USA
Mahwah, NJ 07430
Product of India
February 2024
Other Information
-
•store between 20°C to 25°C (68°F to 77°F)
-
•do not use of imprinted foil inner seal on bottle is broken or missing.
-
•FDA approved organic impurities test procedure differs from USP
Principal Display Panel
Carton label
NDC 72657-129-35
10 mg - 365 Tablets
Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Package/label Principal Display Panel
Container label
NDC 72657-129-35
10 mg - 365 Tablets
Structured Label Content
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
Cetirizine Hydrochloride Tablets, USP 5 mg
|
adults and children 6 years and over |
1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours. |
|
adults 65 years and over |
1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours. |
|
children under 6 years of age |
ask a doctor |
|
consumers with liver or kidney disease |
ask a doctor |
Cetirizine Hydrochloride Tablets, USP 10 mg
|
adults and children 6 years and over |
one 10 mg tablet once daily; do not take more than one 10 mg tablet 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 |
Warnings and Precautions (34071-1)
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine
Ask a doctor before useif 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
-
•avoid alcoholic drinks
-
•alcohol, sedatives, and tranquilizers may increase drowsiness
-
•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.
Section 51727-6 (51727-6)
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Section 55105-1 (55105-1)
Antihistamine
Section 55106-9 (55106-9)
Cetirizine HCl 5 mg
Cetirizine HCl 10 mg
Section 60561-8 (60561-8)
Questions or comments?
call toll-free weekdays 9 AM to 5 PM EST at 1 (888) 721-7115
Manufactured by:
Glenmark Pharmaceuticals Limited
Pithampur, Madhya Pradesh 454775, India
Distributed by:
Glenmark Therapeutics Inc., USA
Mahwah, NJ 07430
Product of India
February 2024
Other Information (Other information)
-
•store between 20°C to 25°C (68°F to 77°F)
-
•do not use of imprinted foil inner seal on bottle is broken or missing.
-
•FDA approved organic impurities test procedure differs from USP
Principal Display Panel
Carton label
NDC 72657-129-35
10 mg - 365 Tablets
Keep Out of Reach of Children. (Keep out of reach of children.)
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Container label
NDC 72657-129-35
10 mg - 365 Tablets
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:55.826520 · Updated: 2026-03-14T23:08:22.901159