MedPath

Allergy Relief

CVS 44-068

Approved
Approval ID

3f05a2f5-b4e9-4f8c-8c3e-1338b4b741ae

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

CVS PHARMACY

DUNS: 062312574

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 Code69842-174
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (10)

DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 20 mL
Code: TC2D6JAD40
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
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
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

Principal display panel

♥CVS
Health®

Dye Free

MAXIMUM
STRENGTH
Allergy
****Relief

LIQUID MEDICATION

DIPHENHYDRAMINE HCI
** 50 mg per 20 mL**
** ORAL SOLUTION**
** Antihistamine**

DYE
** FREE**

****Relieves:
****• Sneezing
****• Runny nose
****• Itchy, watery eyes
****• Itchy throat

Grape Flavor

No Added Alcohol
Actual Bottle Size
on Side Panel
Ages 12 Years and Over

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
** SEAL UNDER CAP IS BROKEN OR MISSING**

Package Contains One Bottle

Actual Size

50844 REV0323A06836

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-18615

CVS® Quality
Money Back Guarantee

#508424

CVS 44-068

CVS 44-068

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/23/2025

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: 9/23/2025

Active ingredient (in each 20 mL)

Diphenhydramine HCl 50 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/23/2025

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 9/23/2025

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages
  • excitability may occur, especially in children

If pregnant or breast-feeding,

ask a health professional before use.

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: 9/23/2025

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
  • adults and children 12 years and over: take 20 mL every 4 to 6 hours, or as directed by a doctor
  • children under 12 years: do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/23/2025

Other information

*each 20 mL contains: sodium 15 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 9/23/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/23/2025

Questions or comments?

1-800-426-9391

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