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| Product NDC Code | 51316-768 | ||||
|---|---|---|---|---|---|
| Drug Name | Fexofenadine hcl |
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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 | 997420 | ||||
| Application Number | ANDA211075 | ||||
| Labeler Name | CVS | ||||
| 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) Fexofenadine HCl USP, 180 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 12 years of age and take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, 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 ■ 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.Fexofenadine HCL Fexofenadine HCL PROPYLENE GLYCOL SHELLAC D&C RED NO. 33 AMMONIA FD&C BLUE NO. 1 FERROSOFERRIC OXIDE TITANIUM DIOXIDE POLYETHYLENE GLYCOL 8000 CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SILICON DIOXIDE GELATIN FD&C YELLOW NO. 6 HYPROMELLOSE 2910 (3 MPA.S) MICROCRYSTALLINE CELLULOSE HYDROXYPROPYL CELLULOSE (90000 WAMW) STARCH, CORN FEXOFENADINE HYDROCHLORIDE FEXOFENADINE G18 (capsule shaped tablet) (White band in the middle)
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.PDP Fexo 180mg Gelcaps
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 kidney disease. Your doctor should determine if you need a different dose.
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.
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? contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
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 ■ do not take more than directed ■ do not take at the same time as aluminum or magnesium antacids ■ do not take with fruit juices (see Directions)
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ safety sealed: do not use if imprinted safety seal under cap is broken or missing ■ store between 20° and 25°C (68° and 77°F) ■ protect from excessive moisture
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.Do not use if you have ever had an allergic reaction to this product or any of its ingredients
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