Cvs 44-485 Allergy Plus

Cvs 44-485 Allergy Plus
SPL v6
SPL
SPL Set ID 0d2cf481-622f-4262-b0bd-c38fe5de6721
Route
ORAL
Published
Effective Date 2026-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Phenylephrine (10 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Silicon Dioxide Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;485 Shape: oval Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-08-09 Until 2027-10-31

Description

Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Purpose

Antihistamine Nasal decongestant


Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • nasal congestion
    • itching of the nose or throat
    • itchy, watery eyes
  • temporarily relieves these symptoms due to the common cold:
    • nasal congestion
    • runny nose
    • sneezing
  • temporarily relieves sinus congestion and pressure
Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 1 tablet every 4 hours
    • do not take more than 6 tablets in 24 hours
  • children under 12 years: do not use
Do Not Use
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each tablet contains: calcium 25 mg

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • 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, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions Or Comments?

1-800-426-9391

Principal Display Panel

CVSHealth®

Compare to the active ingredients in

Benadryl® Allergy Plus Congestion*

Tablets

Allergy Plus

Congestion Relief

DIPHENHYDRAMINE HCl - Antihistamine

PHENYLEPHRINE HCl - Nasal decongestant

Relief of:

  • Sneezing
  • Runny nose
  • Sinus congestion
  • Sinus pressure
  • Itchy throat
  • Itchy, watery eyes

Actual Size

24 TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED #197895

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson &

Johnson Corporation, owner of the registered trademark Benadryl®

Allergy Plus Congestion.



Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-18615

CVS.com/returnpolicy

100% money back

guaranteed.

50844 ORG122048508

CVS 44-485
When Using This Product
  • do not exceed recommended dosage

  • 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
Stop Use and Ask A Doctor If
  • symptoms do not improve within 7 days or are accompanied by fever

  • nervousness, dizziness, or sleeplessness occur
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 Ingredients (in Each Tablet)

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • difficulty in urination due to enlargement of the prostate gland

  • diabetes

  • thyroid disease

  • heart disease

  • glaucoma

  • high blood pressure

  • a breathing problem such as emphysema or chronic bronchitis
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
    • nasal congestion
    • itching of the nose or throat
    • itchy, watery eyes
  • temporarily relieves these symptoms due to the common cold:
    • nasal congestion
    • runny nose
    • sneezing
  • temporarily relieves sinus congestion and pressure
Purpose

Antihistamine

Nasal decongestant

Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 1 tablet every 4 hours
    • do not take more than 6 tablets in 24 hours
  • children under 12 years: do not use
Do Not Use (Do not use)
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each tablet contains: calcium 25 mg

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • 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, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

CVSHealth®

Compare to the active ingredients in

Benadryl® Allergy Plus Congestion*

Tablets

Allergy Plus

Congestion Relief

DIPHENHYDRAMINE HCl - Antihistamine

PHENYLEPHRINE HCl - Nasal decongestant

Relief of:

  • Sneezing
  • Runny nose
  • Sinus congestion
  • Sinus pressure
  • Itchy throat
  • Itchy, watery eyes

Actual Size

24 TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED #197895

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson &

Johnson Corporation, owner of the registered trademark Benadryl®

Allergy Plus Congestion.



Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-18615

CVS.com/returnpolicy

100% money back

guaranteed.

50844 ORG122048508

CVS 44-485
When Using This Product (When using this product)
  • do not exceed recommended dosage

  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms do not improve within 7 days or are accompanied by fever

  • nervousness, dizziness, or sleeplessness occur
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 Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • difficulty in urination due to enlargement of the prostate gland

  • diabetes

  • thyroid disease

  • heart disease

  • glaucoma

  • high blood pressure

  • a breathing problem such as emphysema or chronic bronchitis
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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