FDA Label for Loratadine

View Indications, Usage & Precautions

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,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 MG/5 ML (120 ML BOTTLE)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 MG/5 ML CARTON (120 ML)

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Better Living Brands Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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) - loratadine fig1

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

Compare to
Children's Claritin^®
active ingredient