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NDC 63187-0541-30 SudoGest 60 mg/1 Details

SudoGest 60 mg/1

SudoGest is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0541-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	63187-0541
Product ID	63187-541_2b08189d-4bcb-475e-aa28-a8f693cffd76
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	SudoGest
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pseudoephedrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	60
Active Ingredient Units	mg/1
Substance Name	PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
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 63187-0541-30 (63187054130)

Pricing Information	N/A
NDC Package Code	63187-541-30
Billing NDC	63187054130
Package	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-541-30)
Marketing Start Date	2018-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 52ab64d7-b4c8-45d1-8e45-271f4dda1420 Details

Active ingredient (in each tablet)

Pseudoephedrine HCl 60 mg

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

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

•: 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 fever

If pregrant 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 25ºC (77ºF); excursions permitted between 15˚-30˚C (59˚-86˚F)
•: see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

(800)-616-2471

Principal display panel

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

NDC 63187-541-30

SudoGest™

NASAL DECONGESTANT 60 mg

Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever

Without Drowsiness

30 TABLETS

Distributed by MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA Rev. 02/13 M-17

50844 REV0712N11312

Repackaged by Proficient Rx LP

Thousand Oaks, CA 91320

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

Major 44-113

INGREDIENTS AND APPEARANCE

SUDOGEST

pseudoephedrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-541(NDC:0904-5125)
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	44;113
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-541-15	15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018
2	NDC:63187-541-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018
3	NDC:63187-541-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018
4	NDC:63187-541-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/01/1994

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-541) , RELABEL(63187-541)

Revised: 1/2021

Document Id: 2b08189d-4bcb-475e-aa28-a8f693cffd76

Set id: 52ab64d7-b4c8-45d1-8e45-271f4dda1420

Version: 3

Effective Time: 20210101