Rite Aid 44-485

Rite Aid 44-485
SPL v8
SPL
SPL Set ID 54623e2e-5f9a-426e-8f7e-ea755ff8b3f8
Route
ORAL
Published
Effective Date 2025-04-08
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 Active Since 2005-08-10

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:
    • nasal congestion
    • runny nose
    • sneezing
    • 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

Compare to the active ingredients in

Benadryl® Allergy Plus Congestion*

ALLERGY PLUS

SINUS RELIEF

PHENYLEPHRINE HCl

DIPHENHYDRAMINE HCl

ANTIHISTAMINE

NASAL DECONGESTANT

RELIEF OF

Sneezing, runny nose, sinus congestion,

sinus pressure, itchy throat,

& itchy, watery eyes

24 

TABLETS

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Benadryl® Allergy Plus Congestion.

50844        ORG122048508

DISTRIBUTED BY:

RITE AID, 200 NEWBERRY COMMONS,

ETTERS, PA 17319 www.riteaid.com

SATISFACTION GUARANETT: If you're not

satisfied, we'll happily refund your money.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

Rite Aid 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
  • heart disease
  • diabetes
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • thyroid disease
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:
    • nasal congestion
    • runny nose
    • sneezing
    • 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)

Compare to the active ingredients in

Benadryl® Allergy Plus Congestion*

ALLERGY PLUS

SINUS RELIEF

PHENYLEPHRINE HCl

DIPHENHYDRAMINE HCl

ANTIHISTAMINE

NASAL DECONGESTANT

RELIEF OF

Sneezing, runny nose, sinus congestion,

sinus pressure, itchy throat,

& itchy, watery eyes

24 

TABLETS

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Benadryl® Allergy Plus Congestion.

50844        ORG122048508

DISTRIBUTED BY:

RITE AID, 200 NEWBERRY COMMONS,

ETTERS, PA 17319 www.riteaid.com

SATISFACTION GUARANETT: If you're not

satisfied, we'll happily refund your money.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

Rite Aid 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)
  • heart disease
  • diabetes
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • thyroid disease
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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