Other
Drug Facts
Childrens Loratadine Solution
FDA Label NDC 37808-131
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Childrens Loratadine (NDC 37808-131). 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 other, active ingredient (in each 5 ml teaspoonful), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml Teaspoonful)
Loratadine 5 mg
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
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
- see bottom panel for lot number and expiration date
- store between 20° and 25°C (68° and 77°F)
Inactive Ingredients
butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.
Questions?
Call 1-866-923-4914
Principal Display Panel - 120 Ml Bottle Carton
Compare to the active ingredient
in Children's Claritin®*
NDC 37808-131-08
Original Prescription
Strength
Non-Drowsy†
H-E-B®
Children's
Allergy
Loratadine
Oral Solution USP,
5 mg/5 mL
(Antihistamine) ALLERGY
Indoor & Outdoor Allergies
Ages 2 years and older
Relief of:
- Sneezing • Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
24
Hour
DYE
FREE
Alcohol Free
Sugar Free
Dosing Cup Enclosed
Grape
Flavor
†When taken as directed.
See Drug Facts Panel.
4 FL OZ (120 mL)
Principal Display Panel (120 mL Bottle Carton)
* Please review the disclaimer below.
