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Drug Facts
Childrens Benadryl Allergy Plus Congestion Solution
FDA Label NDC 50580-341
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 Allergy Plus Congestion (NDC 50580-341). 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, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 5 mL) | Purposes |
|---|---|
| Diphenhydramine HCl 12.5 mg | Antihistamine |
| Phenylephrine HCl 5 mg | Nasal decongestant |
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
- nasal congestion
- stuffy nose
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- nasal congestion
- stuffy nose
- temporarily relieves sinus congestion and pressure
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When Using This Product
- do not exceed recommended dose
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 hours
- do not take more than 6 doses in 24 hours
| Age (yr) | Dose (mL) |
|---|---|
| children under 4 years | do not use |
| children 4 to 5 years | do not use unless directed by a doctor |
| children 6 to 11 years | 5 mL |
| adults and children 12 years and over | 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). Protect from light.
Store in outer carton until contents are used. - do not use if bottle wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Questions Or Comments?
call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NDC 50580-341-01
Children's
Benadryl®
ALLERGY PLUS
CONGESTION
Diphenhydramine HCl / antihistamine
Phenylephrine HCl / nasal decongestant
oral solution
4 Hours/Dose
RELIEF OF:
✓ Runny Nose✓ Sneezing✓ Itchy, Watery Eyes✓ Itchy Throat or Nose✓ Sinus Congestion✓ Stuffy Nose
Alcohol Free
Sugar Free
ALLERGY + CONGESTION RELIEF
Grape!
Flavored Liquid
4 fl oz (118 mL)
Principal Display Panel (Childrens 01)
* Please review the disclaimer below.
