Childrens Non-drowsy
FDA Label NDC 21130-787

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway Inc. for the product Childrens Non-drowsy (NDC 21130-787). 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, active ingredient (in each 5 ml), purpose, uses, 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

Other

Drug Facts

DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99, PLEASANTON, CA 94566-0009

Active Ingredient (In Each 5 Ml)

Loratadine 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

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 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.

Directions

adults and children 6 years and over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney diseaseask a doctor

Other Information

  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 2° and 25°C (36° and 77°F)

Inactive Ingredients

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Principal Display Panel - 120 Ml Bottle Carton

NDC 21130-787-29

Compare to
Children's Claritin®
active ingredient†

Children's
Non-Drowsy*

24-Hour
Allergy Relief

Loratadine Oral Solution
5 mg/5 mL
Antihistamine

Relieves:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itching of Nose & Throat

    • Ages two years and older

    *When taken as directed.
    See Drug Facts panel.

    Dosage cup enclosed
    Dye-Free

    Grape Flavored
    Alcohol Free

    4 FL OZ
    (120 mL)

    SAFEWAY ™

    Principal Display Panel (120 mL Bottle Carton)

    Principal Display Panel (120 mL Bottle Carton)

* Please review the disclaimer below.