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| Product NDC Code | 41250-784 | ||
|---|---|---|---|
| Drug Name | Fexofenadine 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 | ||
| RxCUI drug identifier | 997420 | ||
| Application Number | ANDA076502 | ||
| Labeler Name | Meijer Distribution, Inc | ||
| 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 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 180 mg adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet 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
| adults and children 12 years of age and over | take one 180 mg tablet with water once a day; do not take more than 1 tablet 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, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and 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) Allergy temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat Hives reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.
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 Hydrochloride Fexofenadine hydrochloride Fexofenadine Hydrochloride FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM magnesium stearate mannitol POWDERED CELLULOSE FD&C RED NO. 40 HYPROMELLOSE 2910 (6 MPA.S) FERROSOFERRIC OXIDE polyethylene glycol 400 TITANIUM DIOXIDE STARCH, CORN 194;R containercarton
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 Container Carton Label: 30 count
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 safety sealed: do not use if carton is opened or if individual blister units are torn or opened.
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 Allergy kidney disease. Your doctorshould determine if you need a different dose. Hives 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
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 Allergy if you have ever had an allergic reaction to this product or any of its ingredients. Hives 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
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? call toll-free 1-888-375-3784 Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally - 500 090 INDIA
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 Allergy an allergic reaction to this product occurs. Seek medical help right away. Hives 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 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.Storage store between 20° - 25°C (68° - 77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 2.
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 Hives Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom: 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 canbe life threatening if not treated by a health professional immediately .Symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrineinjector for “anaphylaxis” or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.If you have been prescribed an epinephrine injector, you should carry it withyou at all times. Do not use Allergy if you have ever had an allergic reaction to this product or any of its ingredients. Hives 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 Ask a doctor before use if you have Allergy kidney disease. Your doctorshould determine if you need a different dose. Hives 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 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 doctor if Allergy an allergic reaction to this product occurs. Seek medical help right away. Hives 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 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