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| Product NDC Code | 47682-204 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Medique cetiramed |
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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, COATED | ||||||
| RxCUI drug identifier | 1014678 | ||||||
| Application Number | ANDA209274 | ||||||
| Labeler Name | Unifirst First Aid Corporation | ||||||
| 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 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.Directions Adults and children: (6 years and older) one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. Adults over 65 years: 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
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 T emporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose itchy, watery eyes sneezing 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.Medique Cetiramed Cetirizine HCl SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSCARMELLOSE HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE ANHYDROUS LACTOSE MAGNESIUM STEARATE TITANIUM DIOXIDE G;4 (white to off white) (rounded off rectangle)
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.Medique Cetiramed Label Medique® Collect MediBucks See inside flap for more details Cetiramed 24-Hour Allergy Relief 24-horas alivio a las alergias Pull To Open Tire Para Abrir Allergy Relief • Cetirizine HCl 10 mg Alivio a las aletgias • Cetirizina HCl 10 mg 50 Tablets (50 x 1) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias MDQ
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 pharmacists 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 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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 68º and 77ºF (20º and 25ºC) tamper evident sealed packets do not use any opened or torn packets contains no ingredient made from a gluten-containing grain (wheat, barley or rye)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-800-634-7680
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 beverages 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 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 pharmacists before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery
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