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NDC 00904-6728-46 Pseudoephedrine Hydrochloride 60 mg/1 Details

Pseudoephedrine Hydrochloride 60 mg/1

Pseudoephedrine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is PSEUDOEPHEDRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

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: 00904-6728-46
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	00904-6728
Product ID	0904-6728_b61d6e2e-18dc-37d2-e053-2a95a90af57b
Associated GPIs	42101020100310
GCN Sequence Number	005090
GCN Sequence Number Description	pseudoephedrine HCl TABLET 60 MG ORAL
HIC3	B6V
HIC3 Description	DECONGESTANTS, ORAL
GCN	20482
HICL Sequence Number	002091
HICL Sequence Number Description	PSEUDOEPHEDRINE HCL
Brand/Generic	Generic
Proprietary Name	Pseudoephedrine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pseudoephedrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	60
Active Ingredient Units	mg/1
Substance Name	PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Major Pharmaceuticals
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	2024-12-31

Package

Package Images

NDC 00904-6728-46 (00904672846)

Pricing Information
NDC Package Code	0904-6728-46
Billing NDC	00904672846
Package	30 TABLET in 1 BOTTLE (0904-6728-46)
Marketing Start Date	2019-08-29
NDC Exclude Flag	N
Price Per Unit	0.06452
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	SUDOGEST 60 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 78fc7358-75d1-e94a-e053-2a91aa0ab0f1 Details

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 60 mg

SPL UNCLASSIFIED SECTION

Purpose

Nasal decongestant

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure

SPL UNCLASSIFIED SECTION

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

diabetes
heart disease
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland

When using this product do not exceed recommended dose.

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 right away.

Directions

adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
children under 12 years of age: do not use

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

SPL UNCLASSIFIED SECTION

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.

Questions or comments?

(800) 616-2471

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

Distributed by: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL

MAJOR

NDC 0904-6728-52

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

SudoGest TM

Nasal Decongestant 60mg

Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness

100 Tablets

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HYDROCHLORIDE

pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6728
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

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	CPC
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-6728-52	1 in 1 CARTON	08/26/2019
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0904-6728-46	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/26/2019

PSEUDOEPHEDRINE HYDROCHLORIDE

pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6907
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

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	CPC
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-6907-06	5 in 1 BOX	04/11/2019
1		10 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	01/31/2019

Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2020

Document Id: b61d6e2e-18dc-37d2-e053-2a95a90af57b

Set id: 78fc7358-75d1-e94a-e053-2a91aa0ab0f1

Version: 4

Effective Time: 20201210

Search by Drug Name or NDC

NDC 00904-6728-46 Pseudoephedrine Hydrochloride 60 mg/1 Details

Pseudoephedrine Hydrochloride 60 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00904-6728-46 (00904672846)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 78fc7358-75d1-e94a-e053-2a91aa0ab0f1 Details

Drug Facts

SPL UNCLASSIFIED SECTION

Uses

SPL UNCLASSIFIED SECTION

Directions

Other information

SPL UNCLASSIFIED SECTION

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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