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Generic: diphenhydramine hcl, phenylephrine hcl is used for the treatment of Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


IMPRINT: 44 453     SHAPE: round
    COLOR: red

All Imprints

phenylephrine hydrochloride 10 mg - 44 453 round red

phenylephrine hydrochloride 10 mg oral tablet - 44 453 round red

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Active Ingredient (in Each Tablet) (sinus Day)


Phenylephrine HCl 10 mg

Purpose


Nasal decongestant

Active Ingredients (in Each Tablet) (sinus Night)


Diphenhydramine HCl 25 mgPhenylephrine HCl 10 mg

Purpose


AntihistamineNasal decongestant

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • nasal congestion
    • sneezing (Nighttime only)
    • runny nose (Nighttime only)
    • itchy, watery eyes (Nighttime only)
    • itching of the nose or throat (Nighttime only)
  • temporarily relieves these symptoms due to the common cold:
    • nasal congestion
    • sneezing (Nighttime only)
    • runny nose (Nighttime only)
  • temporarily relieves sinus congestion and pressure

Warnings


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 (Nighttime only)

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are


taking sedatives or tranquilizers. (Nighttime only)

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)

Stop use and ask a doctor if

  • symptoms do not improve within 7 days or occur with 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.

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

Directions

  • 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 (Nighttime only)
  • 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(daytime Only)


croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Inactive Ingredients (nighttime Only)


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


NDC 11822-9485-9 Compare to the active ingredients in Sudafed PE® Sinus Congestion Day + Night*

SINUS PRESSURE & CONGESTION RELIEF PE

DAYTIME

PHENYLEPHRINE HCl NASAL DECONGESTANT NON-DROWSY

Relieves nasalcongestion

ACTUAL SIZE

NIGHTTIME

DIPHENHYDRAMINE HClPHENYLEPHRINE HCl ANTIHISTAMINE,NASAL DECONGESTANT

Relieves nasalcongestion,runny nose

ACTUAL SIZE

12 DAYTIME TABLETS

8 NIGHTTIME TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319 www.riteaid.com

SATISFACTION GUARANTEE if you're not satisfied, we'll happily refund your money.

*The product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark SUDAFED PE® SINUS CONGESTION DAY + NIGHT

50844   REV0820D45348509

Do Not Take Daytime and Nighttime Products at the Same Time
Rite Aid 44-453485

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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