First Aid Direct Allergy Relief Tablet
FDA Label NDC 42961-120

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product First Aid Direct Allergy Relief (NDC 42961-120). 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, warnings, do not use, ask a doctor before use if you, 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 Tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporatily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose 
  • itchy, watery eyes
  • sneezing
  • iching of the nose or throat

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 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 accidental overdose, contact a doctor or Poison Control Center immediately. 

Directions

 adults and children 6 years and over​ 1 tablet daily; not more than 1 tablet in 24 hours
 children under 6 years of age ask a doctor
 consumers with liver or kidney disease ask a doctor

Other Information

  • store between 20°C to 25°C (68° to 77°F)
  • protect from excessive moisture
  • do not use if blister unit is torn or open

Inactive Ingredients

lactose monohydrate, magensium stearate, pregelatinized starch, sodium startch glycolate

Questions?

1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)

Principal Display Panel

Original Prescription Strength

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg - Antihistamine

Indoor & Outdoor Allergies

†Compare to active ingredient of Claritin®

Relief of:

  • sneezing 
  • runny nose
  • itchy, watery eyes
  • itchy throat or nose

    • 24 Hour

    Actual Size

    20 TABLETS 

    *When taken as directed. See drug facts panel

    Box-label (Box Label)

    Box-label (Box Label)

* Please review the disclaimer below.