OTC Medication Information: Childrens Benadryl DYE-FREE ALLERGY

CHILDRENS BENADRYL DYE-FREE ALLERGY- diphenhydramine hydrochloride solution
Johnson & Johnson Consumer Inc.

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

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 10 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton tape or bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

call 1-877-717-2824 or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-535-01

Children’s
Benadryl ®

DYE-FREE 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

✔ Free Of:

  • Dyes
  • Alcohol
  • Sugar
  • Parabens
  • High Fructose
    Corn Syrup

Bubble Gum!
Flavored Liquid

4 fl oz (118 mL)

Principal Display Panel
(click image for full-size original)
CHILDRENS BENADRYL DYE-FREE ALLERGY
diphenhydramine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-535
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
GLYCERIN
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL SOLUTION
Product Characteristics
Color white (Clear, colorless) Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50580-535-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (50580-535-01)
2 NDC:50580-535-08 1 BOTTLE in 1 CARTON contains a BOTTLE
2 236 mL in 1 BOTTLE This package is contained within the CARTON (50580-535-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 07/01/2008
Labeler — Johnson & Johnson Consumer Inc. (878046358)

Revised: 03/2024 Johnson & Johnson Consumer Inc.

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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