DrugCite

CHILDRENS BENADRYL ALLERGY - diphenhydramine hydrochloride liquid 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Children's
Benadryl®
ALLERGY

Drug Facts

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = one pre-filled spoon

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

Warnings

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 you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • 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

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
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
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 1 to 2 pre-filled spoons
adults and children 12 years and over 2 to 4 pre-filled spoons

Other information

  • each pre-filled spoon contains: sodium 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • SAFETY SEALED: This product is protected by sealed pouches. Do not use if individual pouches are torn or damaged
  • see side panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

call 1-877-717-2824

PRINCIPAL DISPLAY PANEL

NDC 50580-334-10

THE HISTAMINE BLOCKER™
children's
Benadryl
®

ALLERGY
Diphenhydramine HCI oral solution
Antihistamine

Perfect Measure®

RELIEVES

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

ON-THE-GO
ALLERGY RELIEF

10
PRE-FILLED SINGLE USE SPOONS*
0.17 FL OZ (5 mL) EACH
*12.5 mg Diphenhydramine HCl each

Cherry
FLAVORED LIQUID
Alcohol Free

Principal Display Panel

CHILDRENS BENADRYL ALLERGY 
diphenhydramine hydrochloride  liquid
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 50580-334
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 12.5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
D&C red NO. 33  
FD&C red NO. 40  
glycerin  
glycyrrhizin, ammoniated  
poloxamer 407  
water  
sodium benzoate  
sodium chloride  
sodium citrate  
sucrose  
Product Characteristics
Color RED Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 50580-334-10 10 POUCH In 1 CARTON contains a POUCH
1 5 mL In 1 POUCH This package is contained within the CARTON (50580-334-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/01/2023

Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)
Revised: 04/2011McNeil Consumer Healthcare Div. McNeil-PPC, Inc