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

Purpose

Antihistamine Nasal decongestant 

Description

Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg 


Medication Information

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

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

Description

Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg 

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
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 
Questions Or Comments?

1-800-426-9391

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

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

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
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 
Questions Or Comments? (Questions or comments?)

1-800-426-9391

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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