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| Product NDC Code | 57483-240 | ||||
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| Drug Name | Crcle fexofenadine hydrochloride |
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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 | 997420, 997501 |
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| Application Number | ANDA211075 | ||||
| Labeler Name | Innovus Pharmaceuticals, 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 Fexofenadine HCl USP 60 mg (for 60 mg) Fexofenadine HCl USP 180 mg (for 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 over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg) take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
| adults and children 12 years of age and over | |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, 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.Crcle Fexofenadine Hydrochloride Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE CROSCARMELLOSE SODIUM FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (15 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 6000 SILICON DIOXIDE STARCH, CORN TITANIUM DIOXIDE Peach G5 Crcle Fexofenadine Hydrochloride Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE CROSCARMELLOSE SODIUM FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (15 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 6000 SILICON DIOXIDE STARCH, CORN TITANIUM DIOXIDE peach capsule shaped G6
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.C'rcle Allergy Relief Fexofenadine HCl Tablets, USP 60 mg Antihistamine 100 Tablets NDC 57483-240-02 C'rcle Allergy Relief Fexofenadine HCl Tablets, USP 180 mg Antihistamine 150 Tablets Fexofenadine 60 mg Fexofenadine 180 mg
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.
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.
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Safety-sealed: do not use if imprinted foil under bottle cap is opened or torn. store between 20º and 25ºC (68º and 77ºF) protect from excessive moisture
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 1-877-770-3183 : 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.
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. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. 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) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away
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