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| Product NDC Code | 69168-413 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Allergy relief |
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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 | CAPSULE, COATED | ||||||||
| Application Number | ANDA211075 | ||||||||
| Labeler Name | Allegiant Health | ||||||||
| 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(s) Fexofenadine HCl 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 180 mg caplet with water, once a day; do not take more than 1 caplet in 24 hours 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (black iron oxide), hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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.Use(s) 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.Allergy Relief Fexofenadine HCl FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM FERROSOFERRIC OXIDE HYPROMELLOSE, UNSPECIFIED FERRIC OXIDE RED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN TITANIUM DIOXIDE 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.Principal Display Panel Allergy Relief Fexofenadine Allergy Relief Fexofenadine
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.Other information protect from excessive moisture do not use if imprinted seal under safety cap is broken or missing [for bottle] do not use if blister unit is torn or open [for blister]
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 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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) 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 Call 1-888-952-0050 Monday through Friday 9AM - 5PM
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 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 feedingPregnancy/Breastfeeding ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Storage store at room temperature 20°– 25°C (68°– 77°F)
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 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 if an allergic reaction to this product occurs. Seek medical help right away. Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) 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