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| Product NDC Code | 58602-426 | ||||||
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| Drug Name | 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 | SUSPENSION | ||||||
| RxCUI drug identifier | 997491 | ||||||
| Application Number | ANDA213466 | ||||||
| Labeler Name | Aurohealth LLC | ||||||
| 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.Drug Facts Active ingredient (in each 5 mL) Fexofenadine Hydrochloride USP 30 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 shake well before using use only with enclosed dosing cup adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours children 2 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 2 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Note: mL = milliliters
| adults and children 12 years of age and over | take 10 mL every 12 hours; do not take more than 20 mL in 24 hours |
| children 2 to under 12 years of age | take 5 mL every 12 hours; do not take more than 10 mL in 24 hours |
| children under 2 years of age | ask a doctor |
| adults 65 years of age and older | ask a doctor |
| consumers with kidney disease | ask a doctor |
| Note: mL = milliliters | |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients art strawberry flavor, dibasic sodium phosphate anhydrous, edetate disodium, ethylparaben, methylparaben, modified food starch (corn), monobasic sodium phosphate, poloxamer 407, propylene glycol, purified water, sucrose, titanium dioxide, triacetin, xanthan gum, xylitol.
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 Hydrochloride Fexofenadine Hydrochloride Oral Fexofenadine Hydrochloride Fexofenadine STRAWBERRY SODIUM PHOSPHATE, DIBASIC, ANHYDROUS EDETATE DISODIUM ETHYLPARABEN METHYLPARABEN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE POLOXAMER 407 PROPYLENE GLYCOL WATER SUCROSE TITANIUM DIOXIDE TRIACETIN XANTHAN GUM XYLITOL
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.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz.(240 mL Bottle) Container Label AUROHEALTH NDC 58602-426-20 Ages 2 Years & Older NON-DROWSY Children’s Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL antihistamine INDOOR / OUTDOOR ALLERGY RELIEF Dosing Cup Included Wash and let air dry after each use 12 HR Berry FLAVOR Alcohol & Dye FREE 8 fl. oz. (240 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ Container Label (240 mL Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz. (240 mL Bottle) Carton Container Label AUROHEALTH NDC 58602-426-20 # Compare to the active Ingredient in Children’s Allegra ® Allergy Ages 2 Years & Older Children’s Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL antihistamine 12 HR NON-DROWSY Liquid INDOOR / OUTDOOR ALLERGY RELIEF √ Sneezing √ Runny Nose √ Itchy, Watery Eyes √ Itchy Nose or Throat Use Only With Enclosed Dosing Cup Wash and let air dry after each use Berry FLAVOR Alcohol & Dye FREE 8 fl. oz. (240 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ Carton Container Label (240 mL Bottle)
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 each 5 mL contains: phosphorus 15 mg and sodium18 mg safety sealed: do not use if carton is opened or seal under cap opening is broken or missing store between 20° to 25°C (68° to 77°F)
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 (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 or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016
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.
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