WAL-PHED PE, MULTI-SYMPTOM, DAYTIME, NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit

Wal-Phed by

Drug Labeling and Warnings

Wal-Phed by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)(Daytime only)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant 

Active ingredients (in each caplet) (Nighttime only)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Nasal decongestant 

Uses(Daytime only)

• temporarily relieves these symptoms due to the common cold:
  • headache
  • nasal congestion
  • sore throat
  • cough
  • minor aches and pains
    
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily reduces fever

Uses(Nighttime only)

• temporarily relieves these common cold and flu symptoms:
  
  • runny nose and sneezing
    
  • minor aches and pain
  • sore throat
  • headache
  • nasal congestion
• temporarily reduces fever
  

Warnings

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

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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

• if you have ever had an allergic reaction to this product or any of its ingredients
• 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. 
• with any other drug containing diphenhydramine, even one used on skin (Nighttime only)
• for children under 12 years of age (Nighttime only)
  

Ask a doctor before use if you have

• heart disease
• high blood pressure
• liver disease
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland
• cough that occurs with too much phlegm (mucus) (Daytime only)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
• 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 the blood thinning drug warfarin
• taking sedatives or tranquilizers (Nighttime only)
  

When using this product

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

Stop use and ask a doctor if

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

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

Directions(Daytime only)

• do not use more than directed
  
• adults and children 12 years and over
  • take 2 caplets every 4 hours
  • do not take more than 10 caplets in 24 hours
• children under 12 years: ask a doctor

Directions(Nighttime only)

• do not use more than directed
  
• adults and children 12 years and over
  • take 2 caplets every 4 hours
  • do not take more than 12 caplets in 24 hours
• children under 12 years: do not use

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 (Daytime only)

corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide 

Inactive ingredients(Nighttime only)

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

Questions or comments?

1-800-426-9391

Principal Display Panel

DAY & NIGHT PACK   NDC: 0363-0192-08

• Walgreens DAYTIME NON-DROWSY Wal-Phed® PE PRESSURE + PAIN + COLD ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCERDEXTROMETHORPHAN HBr / COUGH SUPPRESSANTGUAIFENESIN / EXPECTORANTPHENYLEPHRINE HCl / NASAL DECONGESTANT MULTI-SYMPTOM Relieves sore throat, head& body aches, sinuspressure & congestion,cough & chestcongestion ACTUAL SIZE 12 CAPLETS:

  Compare to Sudafed PE® ; Day & Night active ingredients††

  NIGHTTIME

  Wal-Phed® PE ; COLD & FLU ;

  ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER; DIPHENHYDRAMINE HCl / ANTIHISTAMINE; PHENYLEPHRINE HCl / NASAL DECONGESTANT

  MULTI-SYMPTOM

  Relieves sore throat, head; & body aches, runny; nose, sinus pressure; & congestion

  ACTUAL SIZE

  12 CAPLETS

TOTAL 24 CAPLETS

DOES NOT CONTAIN GLUTEN

†Walgreens Pharmacist Survey
†This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Day & NIght.

50844 ORG051754654408

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

PHARMACIST Walgreens RECOMMENDED†
Health expertise you rely on, quality you trust.

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2017 Walgreen Co.

Walgreens 44-544546

INGREDIENTS AND APPEARANCE

WAL-PHED  PE, MULTI-SYMPTOM, DAYTIME, NIGHTTIME
acetaminophen, dextromethorphan hbr, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0192

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0192-08	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	02/22/2007

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	12
Part 2	1 BLISTER PACK	12

Part 1 of 2

WAL-PHED  PE, DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;546
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/22/2007

Part 2 of 2

WAL-PHED  PE, NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	44;544
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/19/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/22/2007

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0363-0192)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0363-0192)