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 Bluepoint Laboratories. 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?
Call 1-855-274-4122
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090,
India
For BluePoint Laboratories
Made in India
Code:TS/DRUGS/19/1993
Issued: 06/2020
Package Label-Principal Display Panel - 5 Mg/5 Ml (120 Ml Bottle)
NDC 68001-449-98
Ages
2 years
and older
Loratadine
Oral Solution USP
5 mg/5 mL
Antihistamine
Non-Drowsy*
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
- Dye-Free
- Sugar-Free
- Alcohol Free
Do not use if carton is opened,
or if cap safety seal is broken
or missing.
Indoor & Outdoor Allergies
Contains sodium metabisulfite,
a sulfite that may cause
allergic-type reactions.
* When taken as directed. See Drug Facts Panel.
Grape Flavor
4FL OZ (120 mL)
Package Label-Principal Display Panel - 5 Mg/5 Ml Carton (120 Ml)
NDC 68001-449-98
#Compare to the
active ingredient in
children’s Claritin®
Ages
2years
and older
Loratadine
Oral Solution USP
5 mg/5 mL
Antihistamine
Non-Drowsy*
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy,watery Eyes
- Itchy Throat or Nose
- Dye-Free
Indoor & Outdoor Allergies
Dosing Cup Included
Contains sodium
metabisulfite, a sulfite
that may cause
allergic-type reactions.
* When taken as directed.
See Drug Facts Panel.
Grape
Flavor
4 FL OZ (120 mL)
* Please review the disclaimer below.