FDA Label for Cetirizine Hydrochloride
View Indications, Usage & Precautions
- OTHER
- 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
- IF PREGNANT OR BREAST-FEEDING:
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS (24 HOUR RELIEF)
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS? 1-800-848-0462
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
Cetirizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
CETIRIZINE HCl
10 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
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 | one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. |
adults 65 years | ask a doctor |
children under | ask a doctor |
consumers with liver | 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.
Available overbagged with 10 tablets per bag, NDC 55154-5399-0.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.
Repackaged By:
Cardinal Health
Zanesville, OH 43701
L48853560617
S-9827 R8
1/17
Principal Display Panel
Cetirizine HCl Tablets, USP
10 mg
10 Tablets
* Please review the disclaimer below.