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NDC 00363-0462-08 Wal-Phed PE 4; 10 mg/1; mg/1 Details

Wal-Phed PE 4; 10 mg/1; mg/1

Wal-Phed PE is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine 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: 00363-0462-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

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: 00363-0462-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	00363-0462
Product ID	0363-0462_b384d62c-4f13-4a03-a446-f452a71dcc03
Associated GPIs	43993002300315
GCN Sequence Number	059701
GCN Sequence Number Description	chlorpheniramine/phenylephrine TABLET 4MG-10MG ORAL
HIC3	Z2N
HIC3 Description	1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	25462
HICL Sequence Number	000446
HICL Sequence Number Description	CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL
Brand/Generic	Generic
Proprietary Name	Wal-Phed PE
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Chlorpheniramine maleate and Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	4; 10
Active Ingredient Units	mg/1; mg/1
Substance Name	CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Walgreen Company
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 00363-0462-08 (00363046208)

Pricing Information	N/A
NDC Package Code	0363-0462-08
Billing NDC	00363046208
Package	1 BLISTER PACK in 1 CARTON (0363-0462-08) / 24 TABLET in 1 BLISTER PACK
Marketing Start Date	2005-06-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5bd2ef2c-7eb7-4d57-8c85-691a243f18d8 Details

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- sinus congestion and pressure
- nasal congestion

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.

Ask a doctor before use if you have

high blood pressure
heart disease
thyroid disease
diabetes
glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

do not exceed recommended dosage
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

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.

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: do not use

Other information

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

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

1-800-426-9391

Principal display panel

Walgreens

Compare to Sudafed PE®

Sinus + Allergy active ingredients††

NDC 0363-0462-08

Wal-Phed® PE

SINUS & ALLERGY

CHLORPHENIRAMINE MALEATE 4 mg / ANTIHISTAMINE

PHENYLEPHRINE HCl 10 mg / NASAL DECONGESTANT

MAXIMUM STRENGTH

• Relieves sneezing, itchy eyes, runny nose,

sinus pressure & congestion

• Pseudoephedrine free

24 TABLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DOES NOT CONTAIN GLUTEN

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or

distributed by McNeil Consumer

Healthcare, owner of the registered

trademark Sudafed PE® Sinus + Allergy.

50844 REV0319D46208

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens

100% SATISFACTION

GUARANTEED

Walgreens 44-462

INGREDIENTS AND APPEARANCE

WAL-PHED PE MAXIMUM STRENGTH

chlorpheniramine maleate and phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0462
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;462
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0462-08	1 in 1 CARTON	06/09/2005	02/16/2024
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0363-0462-07	3 in 1 CARTON	06/09/2005	02/16/2024
2		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	06/09/2005	02/16/2024

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-0462)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0462)

Revised: 10/2022

Document Id: b384d62c-4f13-4a03-a446-f452a71dcc03

Set id: 5bd2ef2c-7eb7-4d57-8c85-691a243f18d8

Version: 16

Effective Time: 20221029