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Drug Facts
Childrens Benadryl Dye-free Allergy Solution
FDA Label NDC 50580-535
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Childrens Benadryl Dye-free Allergy (NDC 50580-535). 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, active ingredient (in each 5 ml), purpose, uses, otc - 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
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
Otc - Do Not Use
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
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
Keep Out Of Reach Of Children.
In case of overdose, getmedical 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 takemore 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 10 mg
- store between 20-25°C (68-77°F)
- do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
- see bottom panel for lot number and expiration date
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution
Questions Or Comments?
call 1-877-717-2824 or 215-273-8755 (collect)
Principal Display Panel
NDC 50580-535-01
Children's
Benadryl®
DYE-FREE
ALLERGY
Diphenhydramine HCl /antihistamine
12.5mg/5mL oral solution
4-6 Hours/Dose
RELIEF OF:
✔ Runny Nose✔ Sneezing✔ Itchy,Watery Eyes✔ Itchy Throat or Nose
Alcohol Free
Sugar Free
DYE-FREE
Bubble Gum!
Flavored Liquid
4 fl oz (118mL)
Principal Display Panel (Childrens 01)
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