Medique Loradamed Tablet, Film Coated
FDA Label NDC 85766-117

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sportpharm Llc for the product Medique Loradamed (NDC 85766-117). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Other information

  • store between 68° and 77°F (20° and 25°C )
  • protect from excessive moisture
  • tamper evident sealed packets
  • do not use any opened or torn packets

Otc - Active Ingredient

Active ingredient (in each tablet)

Loratadine 10 mg

Otc - Purpose

Purpose

Antihistamine

Indications & Usage

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

Warnings

Warnings

Otc - Do Not Use

Do not useif 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 haveliver or kidney disease.

Your doctor should determine if you need a different dose.

Otc - When Using

When using this productdo 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 professional 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 (1-800-222-1222).

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:

Ask a doctor

Consumer with liver or kidney disease:

Ask a doctor

Inactive Ingredient

Inactive ingredients

corn starch*, lactose monohydrate, magnesium stearate, pregelatinized corn starch*, pregelatinized starch*, sodium starch glycolate*

* may contain

Otc - Questions

Questions or comments?Call 1-800-634-7680

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