Active Ingredient (In Each Tablet)
Loratadine USP, 10 mg
Loratadine
FDA Label NDC 41520-525
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Loratadine (NDC 41520-525). 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 tablet), 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
- place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Other Information
- Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
- keep in a dry place.
- use tablet immediately after opening individual blister.
Inactive Ingredients
Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate
Questions?
Call 1-800-406-7984
Principal Display Panel
Compare to the active ingredient of Claritin®Reditabs®†
CAREONE®
Original Prescription Strength
Non-Drowsy*
24 hour
ALLERGY RELIEF
Loratadine Orally Disintegrating Tablets, 10 mg/Antihistamine
Indoor & Outdoor Allergies
NO WATER NEEDED · MELTS IN YOUR MOUTH
FOR ADULTS AND CHILDREN SIX YEARS AND OLDER!
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
10 Orally Disintegrating Tablets
*When taken as directed.
See Drug Facts Panel.
DISTRIBUTED BY: AMERICAN SALES COMPANY
5080282/R0211
This Is The 10 Count Blister Carton Label For Careone Loratadine Odt, 10 mg. (Loraodt Claritin)
Compare to the active ingredient of Claritin®RediTabs®†
CAREONE®
Original Prescription Strength
CHILDREN'S Non-Drowsy*
24 hour
ALLERGY RELIEF
Loratadine Orally Disintegrating Tablets, 10 mg/Antihistamine
Indoor & Outdoor Allergies
NO WATER NEEDED • MELTS IN YOUR MOUTH
FOR ADULTS AND CHILDREN SIX YEARS AND OLDER!
Relief of:
10 Orally Disintegrating Tablets
*When taken as directed.
See Drug Facts Panel.
DISTRIBUTED BY: AMERICAN SALES COMPANY
5080281/R0211
This Is The Bottle Carton Label For Careone 10 Count Loratadine Odt, 10 mg (claritin Kids). (Loraodt Claritinkids)
* Please review the disclaimer below.
