good neighbor pharmacy dye-free children’s allergy relief

good neighbor pharmacy dye-free children’s allergy relief
SPL v3
SPL
SPL Set ID f442c61b-7d2c-401c-b862-acbe2282927b
Route
oral
Published
Effective Date 2024-07-09
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 2024-06-24

Purpose

Antihistamine

Description

Diphenhydramine HCl USP 12.5 mg


Medication Information

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.

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.

Description

Diphenhydramine HCl USP 12.5 mg

Principal Display Panel

GOOD NEIGHBOR PHARMACY®

NDC 46122-793-29

Compare to Children’s Benadryl ®Dye-Free active ingredients*

DYE-FREE

CHILDREN’S

Allergy Relief

Indoor & Outdoor Allergies

Diphenhydramine HCl, 12.5 mg/ 5ML oral solution (Antihistamine)

For Relief of:

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

Sugar Free

Bubblegum Flavor

4 FL OZ(118 mL)

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

Use Dosage Cup Included

*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

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

1-866-467-2748

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.

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.

Principal Display Panel (Principal display panel)

GOOD NEIGHBOR PHARMACY®

NDC 46122-793-29

Compare to Children’s Benadryl ®Dye-Free active ingredients*

DYE-FREE

CHILDREN’S

Allergy Relief

Indoor & Outdoor Allergies

Diphenhydramine HCl, 12.5 mg/ 5ML oral solution (Antihistamine)

For Relief of:

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

Sugar Free

Bubblegum Flavor

4 FL OZ(118 mL)

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

Use Dosage Cup Included

*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

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

1-866-467-2748

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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