Family Wellness 44-018

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 2023-12-13

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

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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?

1-800-426-9391

Principal Display Panel

FAMILY

Wellness™

*COMPARE TO THE

ACTIVE INGREDIENT IN

CHILDREN'S BENADRYL^®

DYE-FREE ALLERGY

children's

DYE-FREE

ALLERGY RELIEF

AGES

6 TO 11

YEARS

Diphenhydramine HCl,

12.5 mg

per 5 mL Oral Solution

Antihistamine

Relieves:

•Sneezing • Itchy, watery eyes

• Runny nose • Itchy nose or throat

Alcohol-free

Sugar-free

DYE-FREE

BUBBLE GUM

FLAVOR

4 FL OZ

(118 mL)

NDC 55319-918-36

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue

Inc., owner of the registered trademark Children’s Benadryl®

Dye-Free Allergy. 50844 ORG012301836

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PKWY

CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?

Return within 30 days to the

store of purchase for a refund

(with receipt) or exchange.

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

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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?)

1-800-426-9391

Principal Display Panel

FAMILY

Wellness™

*COMPARE TO THE

ACTIVE INGREDIENT IN

CHILDREN'S BENADRYL^®

DYE-FREE ALLERGY

children's

DYE-FREE

ALLERGY RELIEF

AGES

6 TO 11

YEARS

Diphenhydramine HCl,

12.5 mg

per 5 mL Oral Solution

Antihistamine

Relieves:

•Sneezing • Itchy, watery eyes

• Runny nose • Itchy nose or throat

Alcohol-free

Sugar-free

DYE-FREE

BUBBLE GUM

FLAVOR

4 FL OZ

(118 mL)

NDC 55319-918-36

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue

Inc., owner of the registered trademark Children’s Benadryl®

Dye-Free Allergy. 50844 ORG012301836

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PKWY

CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?

Return within 30 days to the

store of purchase for a refund

(with receipt) or exchange.

Family Wellness 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

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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 find right dose on chart below mL = milliliter only use the dose cup provided take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 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?": "1-800-426-9391", "Principal Display Panel": "FAMILY Wellness™ *COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ® DYE-FREE ALLERGY children's DYE-FREE ALLERGY RELIEF AGES 6 TO 11 YEARS Diphenhydramine HCl, 12.5 mg per 5 mL Oral Solution Antihistamine Relieves: •Sneezing • Itchy, watery eyes • Runny nose • Itchy nose or throat Alcohol-free Sugar-free DYE-FREE BUBBLE GUM FLAVOR 4 FL OZ (118 mL) NDC 55319-918-36 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Children’s Benadryl® Dye-Free Allergy. 50844 ORG012301836 DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PKWY CHESAPEAKE, VA 23320 USA NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or exchange. Family Wellness 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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information