Drug Facts
Drug Facts
Zyrtec Allergy, Lil Drug Store Tablet, Film Coated
FDA Label NDC 66715-9811
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Zyrtec Allergy, Lil Drug Store (NDC 66715-9811). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, do not use, ask a doctor, ask a doctor or pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Active ingredient (in each tablet)
Cetirizine HCl 10 mg
Purpose
Purpose
Antihistamine
Uses
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
Do Not Use
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
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
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When Using This Product
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
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 pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
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)
Directions
Directions
| adults and children 6 years of age 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 kidney disease | ask a doctor |
Other Information
Other information
- store between 20° to 25°C (68° to 77°F)
- do not use if pouch is torn or damaged
- meets USP Dissolution Test 2
Inactive Ingredients
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Questions?
Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
Package Label.Principal Display Panel
Original Prescription Strength
Zyrtec Allergy
Cetirizine HCl tablets
10 mg / antihistamine
Indoor & Outdoor Allergies
24
hour
Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
[tablet image]
1
TABLET 10 mg
[Lil' Drug Store logo]
* Please review the disclaimer below.
