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| Product NDC Code | 40032-653 | ||||||||
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| 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, CHEWABLE | ||||||||
| RxCUI drug identifier | 1014643, 1014674 |
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| Application Number | ANDA206793 | ||||||||
| Labeler Name | Novel Laboratories, 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 chewable tablet For 5 mg: Cetirizine hydrochloride 5 mg For 10 mg: Cetirizine hydrochloride 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 may be taken with or without water For Cetirizine Hydrochloride Chewable Tablets, 5 mg adults and children 6 years 1 to 2 tablets once daily depending upon severity of symptoms; do not take and over 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 ask a doctor age consumers with liver or ask a doctor kidney disease For Cetirizine Hydrochloride Chewable Tablets, 10 mg adults and children 6 one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A years and over 5 mg product may be appropriate for less severe symptoms. adults 65 years and ask a doctor over children under 6 years of age ask a doctor consumers with liver ask a doctor or kidney disease Other information store between 20° to 25°C (68° to 77°F) Do not use if individual blister unit is open or torn
| adults and children 6 years | 1 to 2 tablets once daily depending upon severity of symptoms; do not take |
| and over | 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 | ask a doctor |
| age | |
| consumers with liver or | ask a doctor |
| kidney disease |
| adults and children 6 | one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A |
| years and over | 5 mg product may be appropriate for less severe symptoms. |
| adults 65 years and | ask a doctor |
| over | |
| children under 6 years of age | ask a doctor |
| consumers with liver | ask a doctor |
| or kidney disease |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acesulfame potassium, colloidal silicon dioxide, D&C YELLOW # 10, FD&C RED # 40, FD&C YELLOW # 6, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polacrilex resin, sodium starch glycolate, sucralose and tutti frutti flavor
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 Cetirizine Hydrochloride CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED POLACRILIN ACESULFAME POTASSIUM SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE SUCRALOSE MAGNESIUM STEARATE D&C YELLOW NO. 10 FD&C RED NO. 40 FD&C YELLOW NO. 6 CETIRIZINE HYDROCHLORIDE CETIRIZINE n;5 Cetirizine Hydrochloride Cetirizine Hydrochloride CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED POLACRILIN ACESULFAME POTASSIUM SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE SUCRALOSE MAGNESIUM STEARATE D&C YELLOW NO. 10 FD&C RED NO. 40 FD&C YELLOW NO. 6 CETIRIZINE HYDROCHLORIDE CETIRIZINE n;10
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 For 5 mg Allergy: NDC 40032-653-03 Children's Cetirizine Hydrochloride Chewable Tablets 5 mg ALLERGY Antihistamine Indoor & Outdoor Allergies Tutti-frutti Flavor 6 yrs. & older 30 CHEWABLE TABLETS Container Label Container Carton For 10 mg Allergy: NDC 40032-652-31 Children's Cetirizine Hydrochloride Chewable Tablets 10 mg ALLERGY Antihistamine Indoor & Outdoor Allergies Tutti-frutti Flavor 6 yrs. & older Blister Label Blister Carton NDC 40032-652-30 C:\Users\kvyas\Desktop\Cetirizine HCL\container 1.jpg C:\Users\kvyas\Desktop\Cetirizine HCL\container 2.jpg C:\Users\kvyas\Desktop\Cetirizine HCL\container 3.jpg C:\Users\kvyas\Desktop\Cetirizine HCL\container carton.jpg C:\Users\kvyas\Desktop\Cetirizine HCL\blister.jpg C:\Users\kvyas\Desktop\Cetirizine HCL\blistercarton front.jpg C:\Users\kvyas\Desktop\Cetirizine HCL\blistercarton back.jpg
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 the reach of children In case of overdose, get medical help or contact a Poison Control Center right away at (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 1-866-403-7592 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873
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 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.
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 reactions 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