FDA Label for Childrens Benadryl Allergy
View Indications, Usage & Precautions
Childrens Benadryl Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Kenvue Brands Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg.
Purpose
Antihistamine
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
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
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium-restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
When Using This Product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
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)
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 14 mg
- store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
- do not use if bottle wrap, or foil inner seal imprinted "SAFETY SEAL®" is broken or missing
Inactive Ingredients
anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose
Questions Or Comments?
call 1-877-717-2824 or 215-273-8755 (collect)
Principal Display Panel
NDC 50580-534-04
Children's
Benadryl®
ALLERGY
Diphenhydramine HCl/antihistamine
12.5 mg/5 mL oral solution
4-6 Hours/Dose
RELIEF OF:
✔ Runny Nose✔ Sneezing✔ Itchy, Watery Eyes✔ Itchy Throat or Nose
Alcohol Free
Cherry!
Flavored
4 fl oz (118 mL)
* Please review the disclaimer below.
