NDC 66116-417 Cetirizine Hydrochloride
NDC Product Code 66116-417
Proprietary Name: Cetirizine Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
NDC Code Structure
- 66116 - Medvantx, Inc.
- 66116-417 - Cetirizine Hydrochloride
NDC 66116-417-30
Package Description: 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
NDC Product Information
Cetirizine Hydrochloride with NDC 66116-417 is a product labeled by Medvantx, Inc.. The generic name of Cetirizine Hydrochloride is . The product's dosage form is and is administered via form.
Dosage Form: -
Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Inactive Ingredient(s)
About the Inactive Ingredient(s)The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
- STARCH, CORN (UNII: O8232NY3SJ)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- POVIDONE K29/32 (UNII: 390RMW2PEQ)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Medvantx, Inc.
Labeler Code: 66116
Start Marketing Date: 10-19-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.
* Please review the disclaimer below.
Information for Patients
Cetirizine
Cetirizine is pronounced as (se ti' ra zeen)
Why is cetirizine medication prescribed?
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dus...
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Cetirizine Hydrochloride Product Label Images
Cetirizine Hydrochloride Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
- Active Ingredient (In Each Tablet)
- Purpose
- Uses
- Otc - Do Not Use
- Otc - Ask Doctor
- Otc - Ask Doctor/Pharmacist
- Otc - When Using
- Otc - Stop Use
- Otc - Pregnancy Or Breast Feeding
- Otc - Keep Out Of Reach Of Children
- Directions
- Other Information
- Inactive Ingredients
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
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Otc - When Using
- 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.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding:if breast-feeding: not recommendedif pregnant: ask a health professional before use.
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.
Directions
Adults and children 6 years and overone 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 overask a doctorchildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
Other Information
Store between 20° to 25°C (68° to 77°F).
Inactive Ingredients
Corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide
* Please review the disclaimer below.