DrugCite

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

children's
Benadryl®
ALLERGY

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

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

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 the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

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, 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 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr) Dose (mL or tsp)
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 (1 tsp) to 10 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 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • do not use if bottle wrap, or foil inner seal imprinted "SAFETY SEAL®" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, D&C red no. 33, FD&C red no. 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 50580-534-08

children's
Benadryl® ®

ALLERGY
Diphenhydramine HCl
12.5 mg/5 mL oral solution
Antihistamine

Relieves

✔
Runny Nose
✔
Sneezing
✔
Itchy, Watery Eyes
✔
Itchy Throat

Cherry
FLAVORED LIQUID
Alcohol Free

THE HISTAMINE
BLOCKER ®

8 fl oz
(236 ml)

Principal Display Panel

CHILDRENS BENADRYL ALLERGY 
diphenhydramine hydrochloride  solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 50580-534
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  
ammonium glycyrrhizate  
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 50580-534-04 1 BOTTLE In 1 CARTON contains a BOTTLE
1 118 mL In 1 BOTTLE This package is contained within the CARTON (50580-534-04)
2 50580-534-08 1 BOTTLE In 1 CARTON contains a BOTTLE
2 236 mL In 1 BOTTLE This package is contained within the CARTON (50580-534-08)
3 50580-534-16 2 CARTON In 1 PACKAGE contains a CARTON
3 1 BOTTLE In 1 CARTON This package is contained within the PACKAGE (50580-534-16) and contains a BOTTLE
3 236 mL In 1 BOTTLE This package is contained within a CARTON and a PACKAGE (50580-534-16)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/01/2023

Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)
Revised: 10/2011McNeil Consumer Healthcare Div. McNeil-PPC, Inc