Best Choice Children’s Allergy Liquid Diphenhydramine Hcl

Best Choice Children’s Allergy Liquid Diphenhydramine Hcl
SPL v6
SPL
SPL Set ID 9bf2d698-8394-46c3-b7a9-e99ab6bb88e4
Route
ORAL
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Glycerin Potassium Citrate Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-07

Description

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl USP 12.5 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the throat or nose
Directions
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours 
  • mL = milliliter

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 designed for use with this product. Do not use any other dosing device.

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each 5 mL contains:sodium 3 mg
  • store at room temperature
  • see bottom panel for lot number and expiration date
  • protect from light
  • contains low sodium
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Best Choice ®

NDC 63941-710-04

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S BENADRYL ®DYE-FREE *

DYE-FREE

Children’s

Allergy Liquid

Diphenhydramine HCl/Antihistamine Oral Solution

For Relief of:

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

SUGAR FREE

BUBBLEGUM FLAVOR

Naturally and artificially flavored

4 FL OZ(118 mL)

IMPORTANT:Keep this carton for future reference on full labeling.

www.StopMedicineAbuse.org

*This product is not manufactured or distributed by Johnson & Johnson owner of the registered trademark Children’s Benadryl ®Dye-Free

TEMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

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 at (1-800-222-1222).

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl USP 12.5 mg

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.


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the throat or nose
Purpose

Antihistamine

Directions
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours 
  • mL = milliliter

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 designed for use with this product. Do not use any other dosing device.

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each 5 mL contains:sodium 3 mg
  • store at room temperature
  • see bottom panel for lot number and expiration date
  • protect from light
  • contains low sodium
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (Principal display panel)

Best Choice ®

NDC 63941-710-04

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S BENADRYL ®DYE-FREE *

DYE-FREE

Children’s

Allergy Liquid

Diphenhydramine HCl/Antihistamine Oral Solution

For Relief of:

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

SUGAR FREE

BUBBLEGUM FLAVOR

Naturally and artificially flavored

4 FL OZ(118 mL)

IMPORTANT:Keep this carton for future reference on full labeling.

www.StopMedicineAbuse.org

*This product is not manufactured or distributed by Johnson & Johnson owner of the registered trademark Children’s Benadryl ®Dye-Free

TEMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

When Using This Product (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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl USP 12.5 mg

Ask A Doctor Before Use If the Child Has (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 (Ask a doctor or pharmacist before use if the child is)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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