Drug Facts
SPL UNCLASSIFIED SECTION
CETIRIZINE HCl10 mg TABLETS, USP
Antihistamine
Indoor & Outdoor Allergies
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Active ingredient (in each tablet)
Cetirizine Hydrochloride, USP 10 mg
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
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 (24 Hour Relief)
| 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? 1-800-848-0462
- 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 M on one side of the tablet and C37 on the other side.
NDC 51079-597-20 - 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: Mylan Institutional Inc.Rockford, IL 61103 U.S.A.
S-12769 10/21
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 10 mg
NDC 51079-597-20
Cetirizine HClTablets, USP10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief(See Uses section of enclosed leaflet)
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARETORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Manufactured for: Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.
Made in India
S-12721
Distributed by: Mylan Institutional Inc.Rockford, IL 61103 U.S.A.
- 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.