Gencare Hives Relief Tablet
FDA Label NDC 72090-058

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Gencare Hives Relief (NDC 72090-058). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning:
Get emergency help immediately if you have hives along with any of the following symptoms:
■trouble swallowing
■dizziness or loss of consciousness
■swelling of tongue
■swelling in or around mouth
■trouble speaking
■drooling
■wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do Not Use

■ to prevent hives from any known cause such as:
■ foods ■ insect stings ■medicines ■latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious.
If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
■ 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. ■ hives that are an unusual color, look bruised or blistered ■hives that do not itch

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.
■ symptoms do not improve after 3 days of treatment
■ the hives have lasted more than 6 weeks

Directions

adults and children 12 years of age and over: take one 180mg 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

Other Information

■ Store between 20°C and 25 °C (68 °and 77°F)
■ Protect from excessive moisture

Inactive Ingredient

Colloidal Silicon Dioxide, Croscarmellose Sodium Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol/macrogol, Povidone, Pregelatinized Starch, Red iron oxide, Silica, Titanium dioxide, Yellow iron oxide.

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