Cvs 44-072

Cvs 44-072
SPL v14
SPL
SPL Set ID e958eef1-8aae-4365-ac64-95a9e8e7e0f2
Route
ORAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 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 2020-10-27

Description

Diphenhydramine HCl 50 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 50 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
  • 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
Do Not Use
  • with any other product containing diphenhydramine, even one used on skin

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 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

♥CVS

Health®

Dye Free

MAXIMUM

STRENGTH

Allergy

Relief

LIQUID MEDICATION

DIPHENHYDRAMINE HCI

50 mg/20 mL

ORAL SOLUTION

Antihistamine

Relieves:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

Cherry Flavor

Actual Bottle Size

on Side Panel

Ages 12 Years & Over

4 FL OZ (118 mL)

DYE

FREE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

50844       REV0323A07236

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-18615

✓ CVS® Quality

Money Back Guarantee

Package Contains One Bottle

Actual Size

CVS 44-072
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.

Active Ingredient (in Each 20 Ml)

Diphenhydramine HCl 50 mg

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.


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
  • 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
Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin

Other Information (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 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 (Principal display panel)

♥CVS

Health®

Dye Free

MAXIMUM

STRENGTH

Allergy

Relief

LIQUID MEDICATION

DIPHENHYDRAMINE HCI

50 mg/20 mL

ORAL SOLUTION

Antihistamine

Relieves:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

Cherry Flavor

Actual Bottle Size

on Side Panel

Ages 12 Years & Over

4 FL OZ (118 mL)

DYE

FREE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

50844       REV0323A07236

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-18615

✓ CVS® Quality

Money Back Guarantee

Package Contains One Bottle

Actual Size

CVS 44-072
When Using This Product (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, (If pregnant or breast-feeding,)

ask a health professional before use.

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 20 Ml) (Active ingredient (in each 20 mL))

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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