Active Ingredient(S)
Diphenhydramine HCl 12.5 mg
Foster And Thrive Childrens Allergy Relief Liquid
FDA Label NDC 70677-1012
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 70677-1012). 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), warnings, 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, 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
Warnings
.
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If The Child Has
- glaucoma
- a breathing problem such as chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If The Child Is
taking sedatives or tranquilizers
When Using This Product
- sedatives and tranquilizers may increase drowsiness
- marked drowsiness may occur
- excitability may occur, especially in 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).
Directions
- find right dose on chart below
- mL=milliliter
- measure only with dosing cup provided
- do not use dosing cup with other products
- 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 |
Other Information
- each 5 mL contains: sodium 5 mg
- dosing cup provided
- store between 20°-25°C(68°-77°F)
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, sorbitol.
Questions Or Comments
Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST
Principal Display Panel
NDC 70677-1012-2
COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*
Foster & Thrive TM
Children's Allergy Relief
Diphenhydramine HCl oral solution,
12.5 mg/5ml
ANTIHISTAMINE
Dye Free
4-6 Hours/Dose
Relief of:
- Runny Nose
- Itchy Watery Eyes
- Sneezing
- Itchy Throat or Nose
- Runny Nose
- Itchy Watery Eyes
- Sneezing
- Itchy Throat or Nose
2+ Ages
CHERRY FLAVOR
DOSING CUP INCLUDED
8FL OZ(236 mL)
549ft8label (549ft8label)
549ft8carton (549ft8carton)
NDC 70677-1012-1
COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*
Foster & Thrive TM
Children's Allergy Relief
Diphenhydramine HCl oral solution,
12.5 mg/5ml
ANTIHISTAMINE
Dye Free
4-6 Hours/Dose
Relief of:
2+Ages
CHERRY FLAVOR
DOSING CUP INCLUDED
4FL OZ(118 mL)
549ft4label (549ft4label)
549ft4carton (549ft4carton)
* Please review the disclaimer below.
