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| Product NDC Code | 70692-139 | ||||
|---|---|---|---|---|---|
| Drug Name | Cetirizine hydrochloride |
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| Type | Generic | ||||
| 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 | Strive Pharmaceuticals Inc | ||||
| 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 HCl 10 mg
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.adults & 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: 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
Purpose
Information about the drug product’s indications for use.Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Cetirizine hydrochloride Cetirizine hydrochloride POLYETHYLENE GLYCOL, UNSPECIFIED CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM CROSCARMELLOSE HYPROMELLOSE, UNSPECIFIED CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE SILICON DIOXIDE TITANIUM DIOXIDE 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.Label Carton
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.Keep out of reach of children. OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.■ store at room temperature between 20-25°C (68-77°F). ■ close cap tightly after use. ■ contains no ingredient made from a gluten-containing grain (wheat, barley or rye). TAMPER EVIDENT: Do not use if imprinted safety seal is broken or missing.
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 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 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
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