Loratadine Solution
FDA Label NDC 30142-062

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 30142-062). 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 drug facts, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each 5 mL teaspoonful)
Loratadine USP 5 mg

Purpose

Antihistamine

Uses

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

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

Ask A Doctor Before Use If You Have

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

When Using This Product

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

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-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 (1-800-222-1222) right away.

Directions


  • use only with enclosed dosing cup

    • adults and children 6 years and over
    		2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours 
    children 2 to under 6 years of age
    		1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    children under 2 years of age
    		ask a doctor
    consumers with liver or kidney disease
    		ask a doctor

Other Information

  • each teaspoonful contains: sodium 6 mg
  • do not use if carton is opened, or if cap safety seal is broken or missing.
  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

Questions Or Comments?

1-800-632-6900

DISTRIBUTRD BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

 Code:TS/DRUGS/19/1993





Package Label-Principal Display Panel - 5 Mg/5 Ml  (120 Ml Bottle)

NDC 30142-062-24
Kroger®
Ages 2 Years & Older

children's
Allergy Relief

Loratadine Oral
Solution USP,
5 mg/5 mL

Antihistamine
INDOOR & OUTDOOR
ALLERGIES 

24 HOUR
DYE-FREE
Grape Flavor

4 FL OZ (120 mL)

Package Label-principal Display Panel (5 mg/5 mL (60 mL Bottle))

Package Label-principal Display Panel (5 mg/5 mL (60 mL Bottle))


Package Label-Principal Display Panel - 5 Mg/5 Ml Carton (120 Ml)

COMPARE TO the active ingredient of
CHILDRENS'S CLARITIN® **See side panel
NDC 30142-062-24

Kroger®
Ages 2 Years & Older
Non-Drowsy*
children's
Allergy Relief
Loratadine Oral
Solution USP, 5 mg/5 mL
Antihistamine
INDOOR & OUTDOOR ALLERGIES
24 HOUR RELIEF OF:


Sneezing; Runny Nose;
Itchy,watery Eyes &
Itchy Throat or Nose

Contains sodium metabisulfite,
a sulfite that may cause
allergic-type reactions.

Dosing
Cup Included


DYE-FREE
Grape Flavor

 4 FL OZ (120 mL)

 * When taken as directed.

See Drug Facts Panel.

Package Label-principal Display Panel (5 mg/5 mL Carton (60 mL))

Package Label-principal Display Panel (5 mg/5 mL Carton (60 mL))




* Please review the disclaimer below.