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| Product NDC Code | 62207-891 | ||||||||
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| 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, FILM COATED | ||||||||
| RxCUI drug identifier | 997420, 997501 |
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| Application Number | ANDA211075 | ||||||||
| Labeler Name | Granules India Limited | ||||||||
| 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, 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 | 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 |
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 reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
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 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 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE PEACH G5 Fexofenadine Hydrochloride Fexofenadine Hydrochloride 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 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE PEACH CAPSULE 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 60 mg - 10s Container Label NDC 62207-889-51 New! NON-DROWSY Fexofenadine HCl Tablets, USP 60 mg Hives Antihistamine REDUCES HIVES and 12 HR RELIEVES ITCHING due to hives 10 Tablets *Compare to the active ingredient in Allegra ® Hives 12 HOUR fexofenadine-60mg-10s-label
PRINCIPAL DISPLAY PANEL 60 mg - 10s Container Carton NDC 62207-889-51 New! NON-DROWSY Fexofenadine HCl Tablets, USP 60 mg Hives Antihistamine REDUCES HIVES and RELIEVES ITCHING due to hives 12 HR 10 Tablets *Compare to the active ingredient in Allegra ® Hives 12 HOUR fexofenadine-60mg-10s-carton
PRINCIPAL DISPLAY PANEL 60 mg - Blister Carton NDC 62207-889-60 New! NON-DROWSY Fexofenadine HCl Tablets USP, 60 mg Hives Antihistamine REDUCES HIVES and 12 HR RELIEVES ITCHING due to hives 72 (8 x 9) Tablets *Compare to the active ingredient in Allegra ® Hives 12 HOUR fexofenadine-60mg-blister-carton
PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Label NDC 62207-891-51 New! NON-DROWSY Fexofenadine HCl Tablets, USP 180 mg Hives Antihistamine REDUCES HIVES and 24 HR RELIEVES ITCHING due to hives 10 Tablets *Compare to the active ingredient in Allegra ® Hives 24 HOUR fexofenadine-180mg-10s-label
PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Carton NDC 62207-891-51 New! NON-DROWSY Fexofenadine HCl Tablets, USP 180 mg Hives Antihistamine REDUCES HIVES and 24 HR RELIEVES ITCHING due to hives 10 Tablets *Compare to the active ingredient in Allegra ® Hives 24 HOUR fexofenadine-180mg-10s-carton
PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton NDC 62207-891-58 New! NON-DROWSY Fexofenadine HCl Tablets USP, 180 mg Hives Antihistamine REDUCES HIVES and 24 HR RELIEVES ITCHING due to hives 70 (7 x 10) Tablets *Compare to the active ingredient in Allegra ® Hives 24 HOUR fexofenadine-180mg-blister-carton
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 foil printed with granules logo under bottle cap is opened or torn. store between 20º and 25ºC (68º and 77ºF) protect from excessive moisture
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. 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 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? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST Manufactured By: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Distributed By: Granules USA, Inc. Parsippany, NJ 07054
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 Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking wheezing or problems breathing drooling These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use 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 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 a doctor if 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