Search by Drug Name or NDC

NDC 00363-4385-09 Wal-Phed PE Details

Wal-Phed PE

Wal-Phed PE is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is .

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00363-4385-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 00363-4385-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	00363-4385
Product ID	0363-4385_94233c3d-919a-4364-94cb-9e57a1b16166
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Wal-Phed PE
Proprietary Name Suffix	Daytime / Nighttime
Non-Proprietary Name	Phenylephrine HCl, Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Walgreen Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 00363-4385-09 (00363438509)

Pricing Information	N/A
NDC Package Code	0363-4385-09
Billing NDC	00363438509
Package	1 KIT in 1 CARTON (0363-4385-09) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2018-08-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a61a64b0-737c-4152-9568-377f52f09248 Details

Active ingredient (in each tablet) (Sinus Day)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Active ingredients (in each tablet) (Sinus Night)

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purpose

Antihistamine

Nasal 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 (1-800-222-1222) right away.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT 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: ask a doctor

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

DAY & NIGHT PACK NDC 0363-4385-09

Walgreens

DAYTIME • NON-DROWSY Wal-Phed® PE SINUS CONGESTION PHENYLEPHRINE HCl 10 mg / NASAL DECONGESTANT MAXIMUM STRENGTH • Relieves sinus pressure & congestion • Pseudoephedrine free Actual Size 12 TABLETS	Compare to Sudafed PE® Day + Night Sinus Congestion active ingredients†† NIGHTTIME Wal-Phed® PE SINUS CONGESTION DIPHENHYDRAMINE HCl 25 mg / ANTIHISTAMINE PHENYLEPHRINE HCl 10 mg / NASAL DECONGESTANT • Relieves itchy, watery eyes, runny nose & itchy throat • Pseudoephedrine free Actual Size 8 TABLETS
TOTAL 20 TABLETS

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

†Walgreens Pharmacist Survey

††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Day + Night Sinus Congestion.

50844 REV0118A45348509

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens

100% SATISFACTION

GUARANTEED

Walgreens.com ©2018 Walgreen Co.

Walgreens 44-453485

INGREDIENTS AND APPEARANCE

WAL-PHED PE DAYTIME / NIGHTTIME

phenylephrine hcl, diphenhydramine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-4385

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-4385-09	1 in 1 CARTON; Type 0: Not a Combination Product	08/31/2018	03/18/2024

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BLISTER PACK	12
Part 2	1 BLISTER PACK	8

Part 1 of 2
WAL-PHED PE DAYTIME phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;453
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	08/31/2018

Part 2 of 2
WAL-PHED PE NIGHTTIME diphenhydramine hcl, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
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)
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	11mm
Flavor		Imprint Code	44;485
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	08/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/31/2018	03/18/2024

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-4385)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-4385)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-4385)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(0363-4385)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-4385)

Revised: 8/2022

Document Id: 94233c3d-919a-4364-94cb-9e57a1b16166

Set id: a61a64b0-737c-4152-9568-377f52f09248

Version: 6

Effective Time: 20220803

Search by Drug Name or NDC

NDC 00363-4385-09 Wal-Phed PE Details

Wal-Phed PE

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00363-4385-09 (00363438509)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a61a64b0-737c-4152-9568-377f52f09248 Details

Active ingredient (in each tablet) (Sinus Day)

Purpose

Active ingredients (in each tablet) (Sinus Night)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients (Daytime only)

Inactive ingredients (Nighttime only)

Questions or comments?

Principal Display Panel

INGREDIENTS AND APPEARANCE

Is Breztri Safe To Take With Mullein Tea?

Can You Take A Z-Pak If You Have A Penicillin Allergy?