Childrens Benadryl-D ALLERGY and SINUS

Dosage form: solution
Ingredients: Diphenhydramine hydrochloride 12.5mg in 5mL, Phenylephrine hydrochloride 5mg in 5mL
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
NDC Code: 50580-781

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Childrens Benadryl-D ALLERGY and SINUS

Drug Facts

Active ingredients (in each 5 mL = 1 teaspoonful)Purpose
Diphenhydramine HCl 12.5 mgAntihistamine
Phenylephrine HCl 5 mgNasal 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

Warnings

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

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

If pregnant or breast-feeding, ask a health professional before use.

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; tsp = teaspoonful
  • take every 4 hours
  • do not take more than 6 doses in 24 hours
Age (yr)Dose (mL or tsp)
children under 4 years do not use
children 4 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years 5 mL (1 tsp)
adults and children 12 years and over10 mL (2 tsp)

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 (1 tsp) 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
  • see bottom panel for lot number and expiration date

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

PRINCIPAL DISPLAY PANEL

NDC 50580-781-04

children's
Benadryl-D
®

ALLERGY
& SINUS
Diphenhydramine HCl/antihistamine
Phenylephrine HCl/nasal decongestant
oral solution

Relieves

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat

Diphenhydramine HCl

Sinus Congestion
Stuffy Nose

Phenylephrine HCl

Grape
FLAVORED LIQUID
Alcohol &
Sugar Free

THE HISTAMINE
BLOCKER
®

4 fl oz
(118 ml)

CHILDRENS BENADRYL-D ALLERGY AND SINUS 
diphenhydramine hydrochloride and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-781
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine hydrochloride (diphenhydramine) Diphenhydramine hydrochloride12.5 mg  in 5 mL
Phenylephrine hydrochloride (phenylephrine) Phenylephrine hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
carboxymethylcellulose sodium 
edetate disodium 
FD&C blue no. 1 
FD&C red no. 40 
glycerin 
water 
sodium benzoate 
sodium citrate 
sorbitol 
sucralose 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-781-041 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2008
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 10/2011
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)