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Health mart allergy relief - Medication Information

Product NDC Code 62011-0471
Drug Name

Health mart allergy relief

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Fexofenadine hydrochloride 60 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 997501
Application Number ANDA076447
Labeler Name Strategic Sourcing Services LLC
Packages
Package NDC Code Description
62011-0471-1 12 blister pack in 1 carton (62011-0471-1) / 1 tablet, film coated in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Fexofenadine HCl 60 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 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 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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 colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, 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 • itchy, watery 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.
health mart allergy relief Fexofenadine HCl FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED TITANIUM DIOXIDE Peach 93;7252

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.
Package/Label Principal Display Panel Compare to the active ingredient in Allegra ® Allergy 12 HR ALLERGY Allergy Relief Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine Indoor/Outdoor Allergy Relief of Sneezing ● Runny Nose ● Itchy, Watery Eyes ● Itchy Nose or Throat 12 HR ● Gluten Free ● NON-DROWSY ACTUAL SIZE 12 Tablets 60 mg each 425-w6-allergy-relief

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 (1-800-222-1222).

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? 1-800-719-9260

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.

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)

Pregnancy or breast feeding

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

Storage and handling

Information about safe storage and handling of the drug product.
Other information • do not use if printed blister unit is broken or torn • store between 20 ° -25 ° C (68 ° -77 ° F) • protect from excessive moisture • this product meets the requirements of USP Dissolution Test 3

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 (1-800-222-1222).

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