Loratadine Tablet, Chewable
FDA Label NDC 30142-565

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Loratadine (NDC 30142-565). 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 chewable tablet), purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Chewable Tablet)

Loratadine USP, 5 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

Warnings

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

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

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

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

If pregnant or beast-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 (1800-222-1222).

Directions

  • chew or crush tablets completely before swallowing.

    • adults and children 6 years and over

    chew 2 tablets daily; not more than 2 chewable tablets in 24 hours

    children 2 to under 6 years of age

    chew 1 tablet daily; not more than 1 chewable tablet in 24 hours

    children under 2 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

Other Information

  • phenylketonurics: contains phenylalanine 1.25 mg per tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25°C (68° to 77°F).

Inactive Ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

1800-632-6900

Package/Label Principal Display Panel

30count (Kroger 30ct)

30count (Kroger 30ct)

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