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Fexofenadine hcl - Medication Information

Product NDC Code 68071-2682
Drug Name

Fexofenadine hcl

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
Application Number ANDA204097
Labeler Name NuCare Pharmaceuticals,Inc.
Packages
Package NDC Code Description
68071-2682-3 1 bottle in 1 carton (68071-2682-3) / 30 tablet in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT(S) in each tablet Fexofenadine hydrochloride 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 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 overtake 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, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

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 § sneezing § itchy, watery eyes § 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 HCL Fexofenadine HCL SILICON DIOXIDE HYPROMELLOSE 2910 (6 MPA.S) LIGHT MINERAL OIL MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 6000 POLYSORBATE 80 STARCH, CORN FERRIC OXIDE RED FERRIC OXIDE YELLOW SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE FEXOFENADINE HYDROCHLORIDE FEXOFENADINE J;44

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 pdp

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 • Tamper-Evident: Do not use if printed foil seal under cap is missing • store between 20° and 25°C (68° and 77°F) • protect from excessive moisture Questions? Call 1-800-206-7821 Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar - 509 301, India. Mfg. Lic. No.: 50/MN/AP/2009/F/R Issued: 04/2019

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.

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 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.

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. If pregnant or breast-feeding, ask a health professional before use.

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)

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

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