Otc - Active Ingredient
Cetirizine HCL 10MG
Cetirizine
FDA Label NDC 67046-680
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Contract Pharmacy Services-pa for the product Cetirizine (NDC 67046-680). 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 otc - active ingredient, otc - purpose, warnings, inactive ingredient, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antihistamine
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. (1-800-222-1222)
Inactive Ingredient
corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin
Otc - 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)
Package Label.Principal Display Panel
Cet (Cet)
* Please review the disclaimer below.
