NON-DROWSY WAL-PHED PE TRIPLE RELIEF- acetaminophen, guaifenesin and phenylephrine hcl tablet, film coated 
Walgreen Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Walgreens 44-527C-TR-Delisted

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Expectorant
Nasal decongestant

Uses

  • for the temporary relief of:
    • minor aches and pains
    • nasal congestion
    • sinus congestion and pressure
    • headache
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves nasal congestion due to the common cold and hay fever and other upper respiratory allergies
  • temporarily reduces fever 

Warnings

 Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.
  • 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.
  • 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
  • thyroid disease
  • diabetes
  • liver disease
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse of lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts

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 of symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

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, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0412-08

NON-DROWSY
Wal-Phed® PE
Triple Relief

Acetaminophen 325 mg / Pain Reliever / Fever Reducer
Guafienesin 200 mg / Expectorant
Phenylephrine HCl 5 mg / Nasal Decongestant

• Relieves fever, sinus headache, sinus pressure, nasal congestion & chest congestion

24 COATED CAPLETS

Actual Size

Compare to Sudafed PE® Triple Action™ active ingredientsǂǂ

PSEUDOEPHEDRINE FREE

DOES NOT CONTAIN GLUTEN

ǂWalgreens Pharmacist Study Survey, November 2012.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Triple Action™.
50844      REV0514B52708

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com     ©2014 Walgreen Co.

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

Walgreens 44-527C-TR

Walgreens 44-527C-TR

NON-DROWSY WAL-PHED PE TRIPLE RELIEF 
acetaminophen, guaifenesin and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0412
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize19mm
FlavorMENTHOLImprint Code 44;527
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0412-082 in 1 CARTON08/06/200512/06/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/06/200512/06/2019
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0363-0412)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(0363-0412)

Revised: 11/2017
 
Walgreen Company