Counteract Tablet
FDA Label NDC 54473-166

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Counteract (NDC 54473-166). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each tablet)
Loratadine 10 mg

Otc - Purpose

Purpose
Antihistamine

Indications & Usage

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

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

Warnings

Warnings

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - When Using

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health processional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

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








Storage And Handling

Other information

  • store at 20°-25°C (68°-77°F)
  • protect from excessive moisture

General Precautions

  • do not use if blister unit is broken or torn

Inactive Ingredient

Inactive ingredients  lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Otc - Questions

Questions or comments? 1-800-282-3000

* Please review the disclaimer below.