Cvs 44-017

Cvs 44-017
SPL v10
SPL
SPL Set ID 3f44cff6-240a-4a8d-aaa1-0da75a31a47b
Route
ORAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2020-08-05

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine


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?

1-800-426-9391

Principal Display Panel

♥CVS

Ages

6-11

years



Cherry Flavor

Children’s

Allergy

Relief

Diphenhydramine HCl

12.5 mg / 5 mL

Oral Solution, Antihistamine

Relief of: Sneezing,

Runny nose, Itchy & watery eyes,

Itchy throat

Free of: Parabens & Sugar

No Added Alcohol

4–6

HOURS / DOSE

DYE

FREE

8 FL OZ (237 mL)

dosing cup

included

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

Package Contains

One Bottle

Actual Size

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-39965

100% money back

guaranteed.

CVS.com/returnpolicy

*This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Children’s Benadryl® Allergy.

50844 ORG082401719

CVS 44-017
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
  • a breathing problem such as chronic bronchitis

  • glaucoma

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?)

1-800-426-9391

Principal Display Panel (Principal display panel)

♥CVS

Ages

6-11

years



Cherry Flavor

Children’s

Allergy

Relief

Diphenhydramine HCl

12.5 mg / 5 mL

Oral Solution, Antihistamine

Relief of: Sneezing,

Runny nose, Itchy & watery eyes,

Itchy throat

Free of: Parabens & Sugar

No Added Alcohol

4–6

HOURS / DOSE

DYE

FREE

8 FL OZ (237 mL)

dosing cup

included

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

Package Contains

One Bottle

Actual Size

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-39965

100% money back

guaranteed.

CVS.com/returnpolicy

*This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Children’s Benadryl® Allergy.

50844 ORG082401719

CVS 44-017
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)
  • a breathing problem such as chronic bronchitis

  • glaucoma

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


Raw Label Data

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