Equate 44-018 Reserved 79903-368

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-19

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 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 nose or throat

Directions

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

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

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 4 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments?

1-888-287-1915

Principal Display Panel

equate™

NDC 79903-368-04

Compare

to Children’s

Benadryl®

Dye-Free Allergy

active

ingredient*

children's

ALLERGY

RELIEF

Diphenhydramine HCl,

12.5 mg per 5 mL

Oral Solution

Antihistamine

Sugar-Free

Dye-Free

6-11 YEARS

Relieves:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat

or Nose

4-6

HOURS/

DOSE

Clear

Bubble Gum

Flavored

Dosage Cup

Included

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

DISTRIBUTED BY: Walmart Inc.

Bentonville, AR 72716

PRODUCT OF CHINA

*This product is not manufactured or distributed

by Kenvue Inc., owner of the registered trademark

Children’s Benadryl® Dye-Free Allergy.

50844 ORG072401836

Equate 44-018

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.

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has

glaucoma
a breathing problem such as chronic bronchitis

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 nose or throat

Purpose

Antihistamine

Directions

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

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

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 4 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel

equate™

NDC 79903-368-04

Compare

to Children’s

Benadryl®

Dye-Free Allergy

active

ingredient*

children's

ALLERGY

RELIEF

Diphenhydramine HCl,

12.5 mg per 5 mL

Oral Solution

Antihistamine

Sugar-Free

Dye-Free

6-11 YEARS

Relieves:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat

or Nose

4-6

HOURS/

DOSE

Clear

Bubble Gum

Flavored

Dosage Cup

Included

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

DISTRIBUTED BY: Walmart Inc.

Bentonville, AR 72716

PRODUCT OF CHINA

*This product is not manufactured or distributed

by Kenvue Inc., owner of the registered trademark

Children’s Benadryl® Dye-Free Allergy.

50844 ORG072401836

Equate 44-018

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.

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

Diphenhydramine HCl 12.5 mg

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

glaucoma
a breathing problem such as chronic bronchitis

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Antihistamine", "Directions": "do not take more than directed do not take more than 6 doses in 24 hours mL = milliliter only use the dose cup provided find right dose on chart below take every 4 to 6 hours, or as directed by a doctor 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", "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 4 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Inactive ingredients": "anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum", "Questions or comments?": "1-888-287-1915", "Principal Display Panel": "equate ™ NDC 79903-368-04 Compare to Children’s Benadryl® Dye-Free Allergy active ingredient* children's ALLERGY RELIEF Diphenhydramine HCl, 12.5 mg per 5 mL Oral Solution Antihistamine Sugar-Free Dye-Free 6-11 YEARS Relieves: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 4-6 HOURS/ DOSE Clear Bubble Gum Flavored Dosage Cup Included 4 FL OZ (118 mL) TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING DISTRIBUTED BY: Walmart Inc. Bentonville, AR 72716 PRODUCT OF CHINA *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Children’s Benadryl® Dye-Free Allergy. 50844 ORG072401836 Equate 44-018 ", "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.", "Active ingredient (in each 5 mL)": "Diphenhydramine HCl 12.5 mg", "Ask a doctor before use if the child has": "glaucoma a breathing problem such as chronic bronchitis", "Ask a doctor or pharmacist before use if the child is": "taking sedatives or tranquilizers."}

Equate 44-018 Reserved 79903-368

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information