Loratadineantihistamine
FDA Label NDC 49349-218

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Remedyrepack Inc. for the product Loratadineantihistamine (NDC 49349-218). 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, dosage & administration, storage and handling, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Loratadine 10 mg

 

Otc - Purpose

Antihistamine

 

Indications & Usage

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

if you have ever had an allergic reaction to this product or any of its ingredients

 

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

 

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

 

an allergic reaction to this product occurs. Seek medical help right away.

 

ask a health professional before use.

 

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

 

Dosage & Administration

adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

 

Storage And Handling

  • do not use if printed foil under cap is broken or missing
  • store at 20°-25°C (68°-77°F)

    •  

Inactive Ingredient

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

 

Otc - Questions

1-800-719-9260

 

Package Label.Principal Display Panel Section

DRUG: Loratadineantihistamine antihistamine


GENERIC: Loratadine


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 49349-218-20


ACTIVE INGREDIENT(S):

  • LORATADINE 10mg in 1


    • INACTIVE INGREDIENT(S):

    • LACTOSE MONOHYDRATE
    • POVIDONE
    • MAGNESIUM STEARATE
    • STARCH, CORN


      • COLOR: white


      SHAPE: OVAL


      SCORE: No score


      SIZE: 8 mm


      IMPRINT: L612


      PACKAGING: 100 in 1 VIAL



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