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| Product NDC Code | 47335-344 | ||||||||||
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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 | ANDA090142 | ||||||||||
| Labeler Name | Sun Pharmaceutical Industries, 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 5 mg: 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 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 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 | 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 acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, 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 relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
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 CETIRIZINE HYDROCHLORIDE CETIRIZINE ACESULFAME POTASSIUM SILICON DIOXIDE SUCROSE CROSPOVIDONE FD&C BLUE NO. 2 FD&C RED NO. 40 GUAR GUM MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE STARCH, CORN TALC 343 Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE ACESULFAME POTASSIUM SILICON DIOXIDE SUCROSE CROSPOVIDONE FD&C BLUE NO. 2 FD&C RED NO. 40 GUAR GUM MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE STARCH, CORN TALC 344
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 For 5 mg Hives Relief: Original Prescription Strength NDC 47335-343-16 Children's Cetirizine Hydrochloride Chewable Tablets 5 mg HIVES Relief Antihistamine 24 hour Relief of ITCHING Due to Hives Tutti-frutti Flavor 6 yrs. & older 100 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD. For 10 mg Hives Relief: Original Prescription Strength NDC 47335-344-16 Children's Cetirizine Hydrochloride Chewable Tablets 10 mg HIVES Relief Antihistamine Tutti-frutti Flavor 6 yrs. & older 100 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD. label-5mg-hives-1 label-5mg-hives-2 label-5mg-hives-3 label-5mg-hives-4 label-5mg-hives-5 label-10mg-hives-1 label-10mg-hives-2 label-10mg-hives-3 label-10mg-hives-4 label-10mg-hives-5
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.Questions? Call toll free 1-800-818-4555 weekdays
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. hives that are an unusual color, look bruised or blistered hives that do not itch
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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
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)
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. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks
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) do not use if inner safety seal is open or torn see top layer for lot number and expiration date
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 Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
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