Active Ingredient (In Each Tablet)
Cetirizine Hydrochloride 10 mg
Dr Simi Cetirizine Hydrochloride 10 Mg Tablet, Film Coated
FDA Label NDC 85786-203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr Simi Cetirizine Hydrochloride 10 Mg (NDC 85786-203). 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 active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
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
- 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 breastfeeding, not recommended
- if pregnant, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children
Overdosage
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 Information
Store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and titanium dioxide
Questions Or Comments?
855-280-1079
Other
* This product is not manufactured or distributed by Kenvue Inc., the owner of the registered trademark Zyrtec®.
Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
Package Label.Principal Display Panel
NDC: 85786-203-30
*Compares to Zyrtec® Allergy Original Prescription Strength
Allergy | Indoor & Outdoor Allergies
Cetirizine Hydrochloride
Tablets 10 mg
Antihistamine
24 hour relief of:
· Sneezing
· Runny Nose
· Itchy, Watery Eyes
· Itchy Throat or Nose
30 tablets
10 mg each
* Please review the disclaimer below.
