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 Kroger Company. 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?
1-800-632-6900
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 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.
* Please review the disclaimer below.