Cvs 44-799

Cvs 44-799
SPL v2
SPL
SPL Set ID 4f33c1fb-150b-4083-a9a4-c0fbab4b6133
Route
ORAL
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc

Identifiers & Packaging

Pill Appearance
Imprint: 44;799 Shape: oval Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-27

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
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Directions
  • do not take more than directed
  • do not take more than 6 times in 24 hours
  • adults and children 12 years and over: take 1 caplet 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 caplet contains: calcium 50 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture
  • 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

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 51316-799-08

CVS

actual size

Extra Strength

ALLERGY RELIEF

Diphenhydramine HCl, 50 mg

Antihistamine

Compare to the active ingredient in

Benadryl® Allergy Extra Strength*

24

CAPLETS

Relief of: Itchy & watery eyes,

Runny nose, Itchy throat,

Sneezing

Ages

12 Years

& Over

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

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

of the registered trademark Benadryl® Allergy Extra Strength.

50844   ORG022579908

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2026 CVS/pharmacy

CVS.com®   1-800-SHOP CVS

V-18615

100% money back

guaranteed.


CVS.com/returnpolicy

CVS 44-799

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

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Purpose

Antihistamine 

Directions
  • do not take more than directed
  • do not take more than 6 times in 24 hours
  • adults and children 12 years and over: take 1 caplet 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 caplet contains: calcium 50 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture
  • 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)

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

NDC 51316-799-08

CVS

actual size

Extra Strength

ALLERGY RELIEF

Diphenhydramine HCl, 50 mg

Antihistamine

Compare to the active ingredient in

Benadryl® Allergy Extra Strength*

24

CAPLETS

Relief of: Itchy & watery eyes,

Runny nose, Itchy throat,

Sneezing

Ages

12 Years

& Over

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

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

of the registered trademark Benadryl® Allergy Extra Strength.

50844   ORG022579908

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2026 CVS/pharmacy

CVS.com®   1-800-SHOP CVS

V-18615

100% money back

guaranteed.


CVS.com/returnpolicy

CVS 44-799

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
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 Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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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