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| Product NDC Code | 51824-076 | ||||
|---|---|---|---|---|---|
| Drug Name | Careall cetirizine hcl |
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| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 1014678 | ||||
| Application Number | ANDA209274 | ||||
| Labeler Name | New World Imports | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Cetirizine 10mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Adult and children over 6 years old: One 10mg tablet once daily: no more than one 10mg tablet in 24 hours. A 5mg 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eys, itching of the nose or throat
Purpose
Information about the drug product’s indications for use.Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.CAREALL Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE CROSCARMELLOSE SODIUM SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED White to off white rounded off rectangular G;4
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Cetirizine Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store between 20-25 degrees celcius (68-77 degrees farhenheit). Do not use if imprinted seal under bottle cap is broken or missing You may report side effects 1-888-952-0050
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)If pregnant of breast-feeding: If breast-feeding: not recommended. If pregnant: ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Do not use if you have ever had an allergic reaction to this product or any of its ingredients or 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 sedatives or tranquilizers 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API