Handy Solutions 24 Hour Allergy Tablet, Film Coated
FDA Label NDC 67751-163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Handy Solutions 24 Hour Allergy (NDC 67751-163). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Loratadine 10 mg

Purpose

Antihistamine

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

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

liver or kidney disease. Your doctor should determine if you need a different dose.

When Using This Product

do not take more than directed. Taking more than directed may cause drowsiness.

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.

Directions

Adults and children (12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours

Children under 12 years: do not give to children under 12 years of age

Consumer with liver or kidney disease: ask a doctor before using

Other Information

• Tamper evident sealed packets
• Do not use any opened or torn packets
• Store between 68°F and 77°F (20° and 25°C)
• Protect from excessive moisture

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions Or Comments?

call 1-800-525-5097

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