OTC Medication Information: Childrens Benadryl ALLERGY

CHILDRENS BENADRYL ALLERGY- diphenhydramine hydrochloride solution
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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.

Drug Facts

Active ingredient (in each 5 mL)

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
  • 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)
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 to 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 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • do not use if carton tape or bottle wrap imprinted with “Sealed For Your Safety” is broken or missing

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 or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-534-04

Children’s
Benadryl ®

ALLERGY

Diphenhydramine HCl/antihistamine
12.5 mg/5 mL oral solution

4-6 Hours/Dose

RELIEF OF:

  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Alcohol Free

Cherry!
Flavored

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL
(click image for full-size original)
CHILDRENS BENADRYL ALLERGY
diphenhydramine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC: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, UNSPECIFIED FORM
SUCROSE
Product Characteristics
Color red Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC: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 NDC: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 NDC: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)
4 NDC:50580-534-18 2 CARTON in 1 PACKAGE contains a CARTON
4 1 BOTTLE in 1 CARTON This package is contained within the PACKAGE (50580-534-18) and contains a BOTTLE
4 236 mL in 1 BOTTLE This package is contained within a CARTON and a PACKAGE (50580-534-18)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/01/2008
Labeler — Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 08/2022 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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