Quality Choice Children’s Allergy Relief Dye-free Cherry Flavor 4 Fl Oz 118 Ml

Quality Choice Children’s Allergy Relief Dye-free Cherry Flavor 4 Fl Oz 118 Ml
SPL v1
SPL
SPL Set ID 644f39d8-7cd6-43dd-9265-546d01d32e8c
Route
ORAL
Published
Effective Date 2025-08-22
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

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50567-7

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Section 50568-5

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
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.

Active Ingredient

Diphenhydramine HCl USP 12.5 mg

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, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

*Compare to the Active Ingredient in Children's Benadryl ®Dye-Free

NDC 83324-339-04

Children’s Allergy Relief

Dye-Free

Diphenhydramine HCl ǀ Antihistamine

Oral solution

For Relief of:

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

Sugar-Free

Natural Cherry Flavor

4 FL. OZ. (118 mL)

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

*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark Children’s Benadryl ®Dye–Free.

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

Distributed by: CDMA, INC,

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362


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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50567-7 (50567-7)

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
Section 50570-1 (50570-1)

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
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.

Active Ingredient (Active ingredient)

Diphenhydramine HCl USP 12.5 mg

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, flavors, 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)

*Compare to the Active Ingredient in Children's Benadryl ®Dye-Free

NDC 83324-339-04

Children’s Allergy Relief

Dye-Free

Diphenhydramine HCl ǀ Antihistamine

Oral solution

For Relief of:

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

Sugar-Free

Natural Cherry Flavor

4 FL. OZ. (118 mL)

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

*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark Children’s Benadryl ®Dye–Free.

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

Distributed by: CDMA, INC,

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362


Advanced Ingredient Data


Raw Label Data

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