Active Ingredient(S)
(in each 5 mL teaspoonful)
Loratadine USP, 5mg
Loratadine Solution
FDA Label NDC 69230-322
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Camber Consumer Care Inc for the product Loratadine (NDC 69230-322). 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(s), purpose, use(s), 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
Use(S)
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.
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
• Sodium Free
• do not use if tape imprinted with 'SEALED FORYOUR PROTECTION' on top and bottom flaps of carton is not intact
• store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
ART grape flavor, edetate disodium dihydrate, glycerin, maltitol solution, monobasic sodium phosphate, non crystallizing sorbitol solution, phosphoric acid, propylene glycol, purified water, sodium benzoate and sucralose
Questions Or Comments?
Call
1-888-588-1418
Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.
Principal Display Panel
Loratadine Oral Solution USP, 5 mg/5mL 120 mL Carton Label
Loratadine-os-carton (Loratadine Os Carton)
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