Active Ingredient (In Each Tablet)
Cetirizine hydrochloride USP, 10 mg
Cetirizine Hydrochloride Tablet, Film Coated
FDA Label NDC 48433-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safecor Health, Llc for the product Cetirizine Hydrochloride (NDC 48433-017). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, 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
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
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.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center 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 at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Inactive Ingredients
Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin
Questions?
Call 1-800-447-1006
- Serious side effects associated with use of this product may be reported to this number.
How Supplied
Cetirizine Hydrochloride Tablets, USP are available as follows:
10 mg – White, film-coated, round, biconvex, beveled
edge, unscored tablets debossed with
Mon one side of
the tablet and
C37on the other side.
NDC 48433-017-20 – Unit dose blister packages
of 100 (10 cards of 10 tablets each).
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Code No.: MH/DRUGS/25/NKD/89
Distributed by:
Safecor Health LLC
Rockford, IL 61103 U.S.A.
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL - 10 mg
NDC 48433-017-20
Cetirizine HCl
Tablets, USP
10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief
(See Uses section of Patient Information)
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Code No.: MH/DRUGS/25/NKD/89
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
S-13652
- This unit dose package is not child resistant.
- For institutional use only.
- Keep this and all drugs out of the reach of children.
- This container provides light-resistance.
- See window for lot number and expiration date.
Distributed by:
Safecor Health LLC
Rockford, IL 61103 U.S.A.
Cetirizine HCl Tablets, Usp (Image 01)
Unit Carton (Image 02)
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