Loratadine Solution
FDA Label NDC 21130-042

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc for the product Loratadine (NDC 21130-042). 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?

1-855-274-4122

DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99
PLEASANTON, CA 94566-0009
‡1-888-723-3929

Made in India 

 Code:TS/DRUGS/19/1993

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

NDC 21130-042-24

Signature
care®
Quality Guaranteed

Non-Drowsy*
AGES 2 YEARS & OLDER

LORATADINE
ORAL SOLUTION USP
5 mg/5 mL



Antihistamine
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.

*When taken as directed.
See Drug Facts Panel.

Do not use if carton is opened, or if cap safety seal
is broken or missing.

Indoor & Outdoor Allergies

•    Dye-Free    •    Sugar-Free    •    Alcohol-Free

GRAPE FLAVOR              4 FL OZ (120 mL)

Package Label-principal Display Panel (5 mg/5 mL (120 mL Bottle))

Package Label-principal Display Panel (5 mg/5 mL (120 mL Bottle))

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

Compare to
Children's Claritin®
active ingredient

NDC 21130-042-24

Signature
care®
Quality Guaranteed

Non-Drowsy*
AGES 2 YEARS & OLDER

LORATADINE
ORAL SOLUTION
USP 5 mg/5 mL


Antihistamine

GRAPE FLAVOR

24 Hour Relief of:

•    Sneezing
•    Runny Nose
•    Itchy, Watery Eyes
•    Itchy Throat or Nose

Indoor & Outdoor Allergies
•    DYE-FREE

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

Dosing Cup Included

*When taken as directed.
See Drug Facts Panel.

4 FL OZ (120 mL)

Package Label-principal Display Panel (5 mg/5 mL Carton (120 mL))

Package Label-principal Display Panel (5 mg/5 mL Carton (120 mL))

 

* Please review the disclaimer below.