NDC 62756-542 Fexofenadine Hydrochloride

Fexofenadine Hydrochloride

NDC Product Code 62756-542

NDC 62756-542-15

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC 62756-542-16

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC 62756-542-27

Package Description: 1 BLISTER PACK in 1 CARTON > 5 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-28

Package Description: 9 BLISTER PACK in 1 CARTON > 5 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-29

Package Description: 10 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-30

Package Description: 15 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-64

Package Description: 5 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-66

Package Description: 2 BLISTER PACK in 1 CARTON > 5 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-74

Package Description: 1 BLISTER PACK in 1 CARTON > 5 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-76

Package Description: 10 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-77

Package Description: 9 BLISTER PACK in 1 CARTON > 5 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-78

Package Description: 15 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-83

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC 62756-542-88

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC 62756-542-94

Package Description: 2 BLISTER PACK in 1 CARTON > 5 TABLET, FILM COATED in 1 BLISTER PACK

NDC 62756-542-95

Package Description: 5 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Fexofenadine Hydrochloride with NDC 62756-542 is a a human over the counter drug product labeled by Sun Pharmaceutical Industries, Inc.. The generic name of Fexofenadine Hydrochloride is fexofenadine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Sun Pharmaceutical Industries, Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Fexofenadine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FEXOFENADINE HYDROCHLORIDE 30 mg/1
  • FEXOFENADINE HYDROCHLORIDE 30 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSPOVIDONE (UNII: 68401960MK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sun Pharmaceutical Industries, Inc.
Labeler Code: 62756
FDA Application Number: ANDA091567 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-06-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Fexofenadine

Fexofenadine is pronounced as (fex oh fen' a deen)

Why is fexofenadine medication prescribed?
Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching...
[Read More]

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Fexofenadine Hydrochloride Product Label Images

Fexofenadine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Tablet)

For 30 mg:Fexofenadine HCl, USP 30 mgFor 60 mg:Fexofenadine HCl, USP 60 mgFor 180 mg:Fexofenadine HCl, USP 180 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nose sneezingitchy, watery eyesitching of the nose or throat

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 directeddo not take at the same time as aluminum or magnesium antacidsdo not take with fruit juices (see Directions)

Stop Use And Ask 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.

Directions

For 30mg:adults and children 12 years of age and overtake two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hourschildren 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hourschildren under 6 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctorFor 60mg:adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hourschildren under 12 years of age do not use adults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctorFor 180mg:adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hourschildren under 12 years of age do not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor

Other Information

  • Safety sealed; do not use if inner safety seal is open or tornstore between 20° to 25°C (68° to 77°F)protect from excessive moisture

Inactive Ingredients

Crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

Questions?

Call toll free 1-800-818-4555 weekdays

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