Active Ingredient (In Each 5 Ml Teaspoonful)
Loratadine 5 mg
Childrens Loratadine Oral Solution
FDA Label NDC 0904-6767
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Childrens Loratadine Oral (NDC 0904-6767). 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 active ingredient (in each 5 ml teaspoonful), purpose, uses, do not use, 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
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
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 right away (1-800-222-1222).
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
- do not use if carton is opened, or if printed neckband is broken or missing
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Compare to the active ingredient in Children’s Claritin®
Children’s
Loratadine
Oral Solution,
USP, 5 mg/5 mL
(Antihistamine) ALLERGY
Non-Drowsy†
Indoor & Outdoor Allergies
SUGAR FREE
Dye Free
24 HOUR
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Ages 2 years and older
Dosing Cup Enclosed
Grape Flavor
†When taken as directed. See Drug Facts Panel.
4 FL OZ
(120 mL)
* Please review the disclaimer below.
