LORATADINE - loratadine oral solution 
Better Living Brands LLC

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Loratadine Oral Solution USP 5 mg/5 mL

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:

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



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

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 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) 

LORATADINE 
loratadine oral solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-042
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GRAPE (UNII: 6X543N684K)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorYELLOW (colorless to light yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-042-241 in 1 CARTON09/25/2023
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20893109/25/2023
Labeler - Better Living Brands LLC (009137209)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(21130-042) , MANUFACTURE(21130-042)

Revised: 9/2023
Document Id: b0412b0b-32e8-49a6-b62a-717290693d7e
Set id: f7dc7a3d-6709-d7e7-e053-6394a90acde8
Version: 2
Effective Time: 20230926
 
Better Living Brands LLC