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

Dye-free Children’s Allergy Relief Cherry Flavor 4 Fl Oz 118 Ml
SPL v7
SPL
SPL Set ID 3652ee94-b762-4100-a305-5acbec5f795a
Route
ORAL
Published
Effective Date 2025-10-27
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 2020-03-09

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
    • Itchy 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. (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

5mL to 10 mL

Attention:use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

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?

1-888-287-1915

Principal Display Panel

*Compare to Children's Benadryl ®Dye-Free active ingredient**

NDC 49035-600-04

Dye-Free

Children’s Allergy Relief

Diphenhydramine HCl USP 12.5 mg ǀ Antihistamine

Oral solution

For Relief of:

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

Sugar-Free | Dye-Free

6-11 YEARS

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:

Walmart Inc.,

Bentonville, AR 72716

Satisfaction guaranteed- Or we’ll replace it or give you your money back. For question or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl USP 12.5 mg


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • Runny nose
    • Sneezing
    • Itchy, Watery Eyes
    • Itchy 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. (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

5mL to 10 mL

Attention:use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

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?)

1-888-287-1915

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

*Compare to Children's Benadryl ®Dye-Free active ingredient**

NDC 49035-600-04

Dye-Free

Children’s Allergy Relief

Diphenhydramine HCl USP 12.5 mg ǀ Antihistamine

Oral solution

For Relief of:

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

Sugar-Free | Dye-Free

6-11 YEARS

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:

Walmart Inc.,

Bentonville, AR 72716

Satisfaction guaranteed- Or we’ll replace it or give you your money back. For question or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

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

Diphenhydramine HCl USP 12.5 mg


Advanced Ingredient Data


Raw Label Data

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