CHILDRENS BENADRYL ALLERGY PLUS CONGESTION- diphenhydramine hydrochloride and phenylephrine hydrochloride solution 
Johnson & Johnson Consumer Inc.

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Childrens Benadryl Allergy Plus Congestion

Drug Facts

Active ingredients (in each 5 mL)Purposes
Diphenhydramine HCl 12.5 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

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

Age (yr)Dose (mL)
children under 4 yearsdo not use
children 4 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years5 mL
adults and children 12 years and over10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

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:

Alcohol Free
Sugar Free

ALLERGY + CONGESTION RELIEF

Grape!
Flavored Liquid

4 fl oz (118 mL)

Principal Display Panel
CHILDRENS BENADRYL ALLERGY PLUS CONGESTION 
diphenhydramine hydrochloride and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-341
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-341-011 in 1 CARTON09/30/2014
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/30/2014
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024
Document Id: 0f4cb82d-44f5-cf36-e063-6394a90a1bdf
Set id: b8b75904-3806-4258-89c1-d6ff486ed41c
Version: 8
Effective Time: 20240119
 
Johnson & Johnson Consumer Inc.