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NDC 00363-0111-22 Wal-phed 4; 60 mg/1; mg/1 Details

Wal-phed 4; 60 mg/1; mg/1

Wal-phed is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE 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: 00363-0111-22
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

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

Related Packages: 00363-0111-22
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	00363-0111
Product ID	0363-0111_50430dcd-e5ac-464e-aad8-5ce5ad6a3efd
Associated GPIs	43993002340310
GCN Sequence Number	026792
GCN Sequence Number Description	chlorpheniramine/pseudoephed TABLET 4 MG-60 MG ORAL
HIC3	Z2N
HIC3 Description	1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	44023
HICL Sequence Number	000503
HICL Sequence Number Description	CHLORPHENIRAMINE MALEATE/PSEUDOEPHEDRINE HCL
Brand/Generic	Generic
Proprietary Name	Wal-phed
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chlorpheniramine Maleate and Pseudoephedrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	4; 60
Active Ingredient Units	mg/1; mg/1
Substance Name	CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Walgreen Company
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 00363-0111-22 (00363011122)

Pricing Information	N/A
NDC Package Code	0363-0111-22
Billing NDC	00363011122
Package	2 BLISTER PACK in 1 CARTON (0363-0111-22) / 24 TABLET in 1 BLISTER PACK
Marketing Start Date	1992-12-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8853dcf7-99b3-f943-65c8-2c2be891c14e Details

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Pseudoephedrine HCl 60 mg

Purpose

Antihistamine

Nasal decongestant

Uses

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

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

a breathing problem such as emphysema or chronic bronchitis
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
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
drowsiness may occur
avoid alcoholic beverages
excitability may occur, especially in children
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 to 6 hours. Do not take more than 4 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)
store in a dry place and protect from light
see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

NDC 0363-0111-22

Wal-Phed® D

Sinus & Allergy

CHLORPHENIRAMINE MALEATE 4 mg / ANTIHISTAMINE

PSEUDOEPHEDRINE HCI 60 mg / NASAL DECONGESTANT

MAXIMUM STRENGTH TABLETS

• Relief of runny nose, sneezing, itchy eyes,

sinus congestion & pressure

48 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

50844 REV0619A11122

Walgreens 44-111

INGREDIENTS AND APPEARANCE

WAL-PHED

chlorpheniramine maleate and pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0111
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
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

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

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;111
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0111-22	2 in 1 CARTON	12/16/1992	01/13/2024
1		24 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	12/16/1992	01/13/2024

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-0111)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0111)

Revised: 3/2022

Document Id: 50430dcd-e5ac-464e-aad8-5ce5ad6a3efd

Set id: 8853dcf7-99b3-f943-65c8-2c2be891c14e

Version: 21

Effective Time: 20220305