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Fexofenadine hydrochloride - Medication Information

Product NDC Code 62207-766
Drug Name

Fexofenadine hydrochloride

Type Generic
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Fexofenadine hydrochloride 180 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 997420,
997501
Application Number ANDA211075
Labeler Name Granules India Ltd
Packages
Package NDC Code Description
62207-766-35 25000 tablet in 1 box (62207-766-35)
62207-766-49 1000 tablet in 1 bottle (62207-766-49)
62207-766-51 1 bottle in 1 carton (62207-766-51) / 10 tablet in 1 bottle
62207-766-58 7 blister pack in 1 carton (62207-766-58) / 10 tablet in 1 blister pack
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT(S) 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.
USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, water 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 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-shaped 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 fexodenadine-label1-jpg fexofenadine-60mg-10s-carton fexofenadine-180mg-10s-carton.jpg Fexofenadine-USP-60mg-Label

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. Do not use if carton is opened or if individual blister units are torn or opened. store between 20º and 25ºC (68º and 77ºF) protect from excessive moisture

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

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 you have 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 an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding ask a health professional before use.

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