Active Ingredient (In Each 5 Ml)
Loratadine 5 mg
Childrens Loratadine
FDA Label NDC 33261-908
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Childrens Loratadine (NDC 33261-908). 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), purpose, uses, stop use and ask a doctor if, directions, other information, inactive ingredients, principal display panel - 120 ml bottle carton, 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
Stop Use And Ask A Doctor If
- an allergic reaction to this product occurs. Seek medical help right away.
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
Directions
| adults and children 6 years and over | 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours |
| children 2 to under 6 years of age | 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- safety sealed: do not use if imprinted safety seal is torn or missing
- store between 2° and 25°C (36° and 77°F)
Inactive Ingredients
artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose
Principal Display Panel - 120 Ml Bottle Carton
NDC 33261-908-01
Compare to the
active ingredient
in Claritin®*
GRAPE
FLAVOR
Original
Prescription Strength
Ages two years and older
Children's
Loratadine
Syrup
(Loratadine
Oral Solution)
5 mg/5 mL
Antihistamine
Grape Flavored Syrup
24 hour
Non-Drowsy†
Allergy Relief
Relief of:
Sneezing; Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose
4 FL OZ (120 mL)
† When taken as directed. See Drug Facts Panel.
Image Label (Loratadine Child Soln Taro 1)
* Please review the disclaimer below.
