Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Foster And Thrive Childrens Allergy Relief Solution
FDA Label NDC 70677-1268
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 70677-1268). 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, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, keep out of reach of children., 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:
- sneezing
- itching of the nose or throat
- runny nose
- itchy, watery eyes
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Ask A Doctor Before Use If The Child Has
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If The Child Is
taking sedatives or tranquilizers
When Using This Product
- marked drowsiness may occur
- excitability may occur, especially in children
- sedatives and tranquilizers may increase drowsiness
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
- find right dose on chart below
- mL = milliliter
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
Age (yr) | Dose (mL) |
children under 2 years | do not use |
children 2 to 5 years | do not use unless directed by a doctor |
children 6 to 11 years | 5 mL to 10 mL |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other Information
- each 5 mL contains: sodium 15 mg
- store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
- do not use if printed neckband is broken or missing
Inactive Ingredients
anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution
Questions Or Comments?
Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Principal Display Panel
COMPARE TO CHILDREN’S BENADRYL® ACTIVE INGREDIENT
Foster & Thrive™
Children’s Allergy Relief
Diphenhydramine HCl Oral Solution 12.5 mg/5 mL
ANTIHISTAMINE
Relief of:
• Runny Nose
• Sneezing
• Itchy, Watery Eyes
• Itchy Throat or Nose
Alcohol Free
Ages 6-11
DOSAGE CUP INCLUDED
CHERRY FLAVOR
4 FL OZ (118 mL)
379-km-childrens-allergy-relief.jpg (379 Km Childrens Allergy Relief)
* Please review the disclaimer below.
