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| Product NDC Code | 16571-401 | ||||
|---|---|---|---|---|---|
| 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 | 1014676 | ||||
| Application Number | ANDA077829 | ||||
| Labeler Name | Rising Pharma Holdings, 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.Active Ingredient (in each tablet) Cetirizine HCl USP 5 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.Directions Adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours Adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor
| Adults and children 6 years and over | 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours |
| Adults 65 years and over | 1 tablet once a day; do not take more than 1 tablet in 24 hours |
| 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.Inactive ingredients hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, 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.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
Purpose
Information about the drug product’s indications for use.Purpose Antihistimine
Spl product data elements
Usually a list of ingredients in a drug product.Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine HYPROMELLOSES lactose magnesium stearate starch, corn polyethylene glycol povidone titanium dioxide White Barrel Shaped CTN;5
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.PRINCIPAL DISPLAY PANEL-100'S COUNT Rising NDC 16571-401-10 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine ALLERGY Indoor & Outdoor Allergies 24 Hour Relief of: •Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat or Nose 100 Tablets T10 - M.L. G/1430 cetrizine-5mg-1 cetrizine-5mg-2 cetrizine-5mg-3
T20 - M.L. G/25/2188 cetrizine-5mg-4 cetrizine-5mg-5 cetrizine-5mg-6
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Manufactured by: Unique Pharmaceutical Labs, (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 M.L. G/1430 Jul. 2020 129575
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. In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-844-874-7464
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.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 drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary. 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 Poison Control Center right away. (1-800-222-1222)
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