Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Cetirizine HCl 10 mg
OTC - PURPOSE SECTION
Purpose Antihistamine
Cetirizine hydrochloride tablets USP 10 mg
- Manufacturer
- Northwind Health Company, LLC
- Effective date
- 2026-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:48:38
Key Label Information
Uses
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
Warnings
WARNINGS SECTION
Warnings
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Directions 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
Other Label Information
INACTIVE INGREDIENT SECTION
Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
Principal Display Panel
NDC: 51655-842-60
Products
- Cetirizine Hydrochloride Tablets,10 mg
- CETIRIZINE
NDC Codes
Ingredients
Complete SPL Sections
DRUG FACTS
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Cetirizine HCl 10 mg
OTC - PURPOSE SECTION
Purpose Antihistamine
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
WARNINGS SECTION
Warnings
DOSAGE & ADMINISTRATION SECTION
Directions 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
OTHER SAFETY INFORMATION
Other information • store between 20° to 25°C (68° to 77°F).
INACTIVE INGREDIENT SECTION
Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
Principal Display Panel
NDC: 51655-842-60
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/f756d3b1-d2e4-3705-e053-6294a90aa380/4bbb94e5-ada2-ab07-e063-6394a90a1b01.xml
- XML SHA-256
- f36e84393f530ff4b45c19a5fe743e0b1476f95fe8b67f0b328238fe1bfe48fa
- XML bytes
- 30069
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 4bbb94e5-ada2-ab07-e063-6394a90a1b01.xml | 2026-03-04 |
| otc | 51655-842-60 - Rev A 03-23 NHC.jpg | 2026-03-04 |
| otc | f99da162-f201-1c19-e053-6294a90acffb.xml | 2023-04-20 |
| otc | f86f9af7-fafc-9040-e053-6294a90a1c3c.xml | 2023-04-07 |
| otc | 51655-842-26 - Rev A 02-23.jpg | 2023-03-21 |
| otc | f756daea-1a3d-2c52-e053-6394a90aa140.xml | 2023-03-21 |