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Allegra allergy - Medication Information

Product NDC Code 41167-4122
Drug Name

Allegra allergy

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Fexofenadine hydrochloride 180 mg/1
Route ORAL
Dosage Form TABLET, COATED
RxCUI drug identifier 997420,
997422
Application Number NDA020872
Labeler Name Chattem, Inc.
Packages
Package NDC Code Description
41167-4122-0 1 blister pack in 1 carton (41167-4122-0) / 8 tablet, coated in 1 blister pack
41167-4122-2 1 bottle in 1 carton (41167-4122-2) / 60 tablet, coated in 1 bottle
41167-4122-5 1 bottle in 1 carton (41167-4122-5) / 24 tablet, coated in 1 bottle
41167-4122-6 1 bottle in 1 carton (41167-4122-6) / 32 tablet, coated in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Fexofenadine HCI 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 agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients croscarmellose sodium, D&C red 28, D&C red 33, FD&C blue 1, gelatin, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, PEG-135, pharmaceutical ink, 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 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water 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.
Allegra Allergy Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE CROSCARMELLOSE SODIUM D&C RED NO. 28 D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 6000 STARCH, CORN TITANIUM DIOXIDE White band in the middle AG;AG Caplet

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 NDC 41167-4122-0 Allegra® ALLERGY fexofenadine HCI tablet 180 mg/antihistamine 24 HR 8 GELCAPS NDC 41167-4122-0 Allegra® ALLERGY fexofenadine HCI tablet 180 mg/antihistamine 24 HR 8 GELCAPS

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.
Allegra Allergy® Gelcaps – 24 HO UR Drug Facts Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20 º and 25 º C (68 º and 77 º F) 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. 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)

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.

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 toll-free 1-800-633-1610 or www.allegra.com The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection. Dist. By: Chattem, Inc., a Sanofi Company, Chattanooga, TN 37409-0219 ©2014

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.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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. 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. 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