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

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Walgreens 44-544546-08-H Delisted

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 REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT

MULTI-SYMPTOM

• Relieves sore throat, head
& body aches, sinus
pressure & congestion,
cough & chest
congestion

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 IF 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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0192-08	1 in 1 CARTON; Type 0: Not a Combination Product	02/22/2007	02/20/2023

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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, UNSPECIFIED (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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (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

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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/22/2007	02/20/2023

Labeler - Walgreen Company (008965063)

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

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

Revised: 2/2023

Document Id: 27b577d7-5c56-48f1-8b33-9953f5c46946

Set id: 57d23d57-2e55-4c2d-ad09-f523afc62e13

Version: 7

Effective Time: 20230220

Walgreen Company