Other
Drug Facts
Keep the carton. It contains important information. See end panel for expiration date.
REV: 031-43-01
NDC: 72559-031-43
Distributed by: Little Pharma, Inc.
New York, NY 10023
Tableted and Packaged in USA
Curist Childrens Allergy Relief Tablet, Chewable
FDA Label NDC 72559-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Little Pharma, Inc. for the product Curist Childrens Allergy Relief (NDC 72559-031). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Loratadine USP, 5 mg
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Warnings
Warnings
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).
Dosage & Administration
- chew or crush tablets completely before swallowing.
| adults and children 6 years and over | chew 2 tablets daily; not more than 2 chewable tablets in 24 hours |
| children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 chewable tablets in 24 hours |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Storage And Handling
Other information
- phenylketonurics: contains phenylalanine 1.25 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).
Inactive Ingredient
Inactive ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Otc - Questions
Questions? Call 1-844-243-1241 or email [email protected]
Package Label.Principal Display Panel
curist kids
Children's Allergy Relief
Loratadine Chewable Tablets USP, 5 mg
Antihistamine
Indoor and Outdoor Allergies
24 Hour Relief of Sneezing;
Runny Nose; Itchy, Watery Eyes;
Itchy Throat or Nose
Non-Drowsy*
60 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.
AGES 2+ YEARS
*When taken as directed. See Drug Facts Panel.
Grape Flavored
Dye-Free
curistrelief.com
* Please review the disclaimer below.
