Active Ingredient (In Each Tablet)
Loratadine 5 mg
Foster And Thrive Childrens Allergy Relief Tablet, Chewable
FDA Label NDC 70677-1043
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Foster And Thrive Childrens Allergy Relief (NDC 70677-1043). 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
- chew or crush tablets completely before swallowing
adults and children 6 years and over | chew 2 tablets daily; not more than 2 tablets in 24 hours |
children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 tablet in 24 hours |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
Other Information
- phenylketonurics: contains phenylalanine 1.4 mg per tablet
- do not use if blister unit is broken or torn
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions Or Comments?
Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Principal Display Panel
COMPARE TO CHILDREN’S CLARITIN® CHEWABLES ACTIVE INGREDIENT
Foster & Thrive™
Children’s Allergy Relief
Loratadine Chewable Tablets, 5 mg
ANTIHISTAMINE
2 Years and Older | Non-Drowsy** | 24 Hour
Indoor & Outdoor Allergies
GRAPE FLAVOR
ACTUAL SIZE
Non-Drowsy** Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
**When Taken As Directed. See Drug Facts Panel.
30 CHEWABLE TABLETS
3y8-km-childrens-allergy-relief (Image 01)
* Please review the disclaimer below.
