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| Product NDC Code | 58602-445 | ||||||||||||||||||||||||||||||
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| Drug Name | Cetirizine hydrochloride (allergy) |
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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 | 1014676, 1014678 |
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| Application Number | ANDA090760 | ||||||||||||||||||||||||||||||
| Labeler Name | Aurohealth LLC | ||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) For 5 mg: Cetirizine hydrochloride USP 5 mg For 10 mg: Cetirizine hydrochloride USP 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.Directions For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: adults and 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 of age ask a doctor consumers with liver or kidney disease ask a doctor
| adults and children 6 years and over | 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. |
| adults 65 years and over | 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) 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 | 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 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 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.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 Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white X;35 Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white X;36 Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white off-rectangular X;2;0
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.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label) AUROHEALTH NDC 58602-444-09 * Compare to the active ingredient of Zyrtec ® Original Prescription Strength Allergy Relief Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine Indoor & Outdoor Allergies 5 mg Strength Tablets Take 1 to 2 tablets * once daily depending on the severity of your symptoms * Adults 65 and older take only one tablet per day 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets 5 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label) AUROHEALTH NDC 58602-444-21 * Compare to the active ingredient of Zyrtec ® Allergy Relief Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine Original Prescription Strength Indoor & Outdoor Allergies 5 mg Strength Tablets Take 1 to 2 tablets * once daily depending on the severity of your symptoms * Adults 65 and older take only one tablet per day 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 (10 x 10) unit-dose Tablets 5 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label) AUROHEALTH NDC 58602-445-09 * Compare to the active ingredient of Zyrtec ® Allergy Relief Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine Original Prescription Strength Indoor & Outdoor Allergies 10 mg Strength Tablets 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets 10 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label) AUROHEALTH NDC 58602-445-21 * Compare to the active ingredient of Zyrtec ® Allergy Relief Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine Original Prescription Strength Indoor & Outdoor Allergies 10 mg Strength Tablets 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 (10x10) Tablets 10 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)
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.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
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 a 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 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown, East Windsor, NJ 08520 Made in India
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding: If breast-feeding: not recommended if pregnant: ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING 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.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.
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