MedPath

Allergy Relief

Family Wellness 44-015

Approved
Approval ID

44d9a74a-a27c-4ff2-b8b1-bf63811ecf54

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

Family Dollar Services Inc

DUNS: 024472631

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diphenhydramine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55319-315
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (11)

DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 5 mL
Code: TC2D6JAD40
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

Principal display panel

Family
Wellness™

COMPARE TO THE
** ACTIVE INGREDIENT
*
** IN CHILDREN’S**
** BENADRYL****®**** ALLERGY**

Children's
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

CHERRY
** FLAVOR**

4 FL OZ
** (118 mL)**

NDC 55319-315-36

TAMPER EVIDENT: DO NOT USE IF PRINTED
** NECK WRAP IS BROKEN OR MISSING**

*This product is not manufactured or distributed by Kenvue Inc.,
owner of the registered trademark Children’s Benadryl® Allergy.
50844 REV0724A01536

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 44-015](/dailymed/image.cfm?name=family- wellness-44-015-1.jpg&id=895939)

Family Wellness 44-015




INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/2/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/2/2025

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/2/2025

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 9/2/2025

Warnings

Do not use

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

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.

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/2/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/2/2025

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
  • protect from light

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/2/2025

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/2/2025

Questions or comments?

1-800-426-9391

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