Wal-Phed PE description, usages, side effects, indications, overdosage, supplying and lots more!

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Wal-Phed PE

WALGREEN CO.

Walgreens 44-544


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplets)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenyelphrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Wal-Phed PE Uses

  • temporarily relieves these symptoms of hay fever and the common cold:
    • runny nose
    • sneezing
    • headache
    • sore throat
    • minor aches and pains
    • nasal congestion
  • temporarily relieves these additional symptoms of hay fever:
    • itching of the nose or throat
    • itchy, watery eyes

Warnings

Liver warning: This product contains acetaminophen.  Severe liver damage may occur if you take:

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • with any other product containing diphenhydramine, even one used on skin
  • 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, ask a doctor or pharmacist before taking this product
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • heart disease
  • liver disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery 

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • gever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition. 

If pregnant or breast-feeding,

ask a health professional before use. 

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Directions

  • do not use more than idrected (see overdose warning)
    • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take mroe than 12 caplets in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Wal-Phed PE Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin 

Questions or comments?

1-800-426-9391

Principal display panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0544-09

NIGHTTIME
Wal-Phed® PE
PE Cold
Acetaminophen
325 mg / Pain Reliever / Fever Reducer
Diphenhydramine HCl 25 mg / Antihistamine
Phenylephrine HCl 5 mg / Nasal Decongestant
Relieves: • Sore throat    • Head & body aches    • Runny nose
• Sinus pressure & congestion

20 CAPLETS

Compare to Sudafed PE® Nighttime Cold active ingredientǂǂ

PSEUDOEPHEDRINE FREE

ǂWalgreens Pharmacist Survey Study, November 2010.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Health, Inc., owner of the registered trademark Sudafed® PE Nighttime Cold.
50844    REV0413A54409

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Wal-Phed PE
Walgreens 44-544

Wal-Phed PE

Acetaminophen, Diphenhydramine HCl, Phenyelphrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-5440
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C BLUE NO. 1

Product Characteristics

Color Size Imprint Code Shape
BLUE 16 mm 44;544 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:0363-5440-09 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2006-09-19


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Be sure to consult your doctor before taking any medication!
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