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NDC 00363-0178-22 Wal-Act 60; 2.5 mg/1; mg/1 Details

Wal-Act 60; 2.5 mg/1; mg/1

Wal-Act is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.

Product Information

NDC	00363-0178
Product ID	0363-0178_68adb583-091b-43c8-8a78-b8b4b4d7971a
Associated GPIs	43993002800330
GCN Sequence Number	016947
GCN Sequence Number Description	acetaminophen ORAL SUSP 160 MG/5ML ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	26911
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Wal-Act
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pseudoephedrine HCl and Triprolidine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	60; 2.5
Active Ingredient Units	mg/1; mg/1
Substance Name	PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Labeler Name	Walgreen Company
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], 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 00363-0178-22 (00363017822)

Pricing Information	N/A
NDC Package Code	0363-0178-22
Billing NDC	00363017822
Package	2 BLISTER PACK in 1 CARTON (0363-0178-22) / 24 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	1993-01-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7f1ff0eb-78e9-465d-9ec9-a900fe8bd9c4 Details

Active ingredients (in each tablet)

Pseudoephedrine HCl 60 mg

Triprolidine HCl 2.5 mg

Purpose

Nasal decongestant

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- nasal congestion
- sneezing
- itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- 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
use caution when driving a motor vehicle or operating machinery
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness

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)
see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

NDC 0363-0178-22

COLD & ALLERGY

Wal-Act® D

PSEUDOEPHEDRINE HCl / NASAL DECONGESTANT

TRIPROLIDINE HCl / ANTIHISTAMINE

• Relieves runny nose, nasal congestion,

sneezing & itchy, watery eyes

48

TABLETS

ONE TABLET PER DOSE

ACTUAL SIZE

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

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844 REV0719B17822

Walgreens 44-178

INGREDIENTS AND APPEARANCE

WAL-ACT

pseudoephedrine hcl and triprolidine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0178
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;178
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0178-22	2 in 1 CARTON	01/09/1993	02/18/2024
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	01/09/1993	02/18/2024

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-0178)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-0178)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0178)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(0363-0178)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-0178)

Revised: 11/2022

Document Id: 68adb583-091b-43c8-8a78-b8b4b4d7971a

Set id: 7f1ff0eb-78e9-465d-9ec9-a900fe8bd9c4

Version: 13

Effective Time: 20221119