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NDC 58602-0804-83 Pseudoephedrine HCl 120 mg/1 Details

Pseudoephedrine HCl 120 mg/1

Pseudoephedrine HCl is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. 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: 58602-0804-83
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	58602-0804
Product ID	58602-804_5f73d533-1e3b-4e36-8bea-6076b9d0a9b5
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	Pseudoephedrine HCl
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pseudoephedrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	120
Active Ingredient Units	mg/1
Substance Name	PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Aurohealth LLC
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209008
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58602-0804-83 (58602080483)

Pricing Information	N/A
NDC Package Code	58602-804-83
Billing NDC	58602080483
Package	1 BLISTER PACK in 1 CARTON (58602-804-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2017-06-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1056d9da-8a3f-4b7a-878e-7f8d45d298cd Details

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl USP 120 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

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

When using this product do not exceed recommended dosage

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. (1-800-222-1222)

Directions

adults and children 12 years and over	take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours
children under 12 years	do not use this product in children under 12 years of age

Other information

Each tablet contains: calcium 36 mg
store at 20° to 25°C (68° to 77°F). Protect from light.
do not use if the individual blister unit is open or torn
see side panel for lot number and expiration date
Meets USP dissolution test 4

Inactive ingredients

colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

Questions or comments?

call 1-855-274-4122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

AUROHEALTH

Compare to the active ingredient in

Sudafed® 12 Hour**

NDC 58602-804-67

MAXIMUM STRENGTH

Long-Acting Nasal Decongestant

Pseudoephedrine HCl

Extended-Release Tablets USP 120 mg

• SINUS PRESSURE

• CONGESTION

• NON-DROWSY

12 HOUR

20 COATED CAPLETS*

120 mg EACH

*CAPSULE-SHAPED TABLETS

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HCL

pseudoephedrine hcl tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-804
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	70;T
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-804-83	1 in 1 CARTON	06/09/2017
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:58602-804-67	2 in 1 CARTON	06/09/2017
2		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
ANDA	ANDA209008	06/09/2017

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-804) , MANUFACTURE(58602-804)

Revised: 11/2022

Document Id: 5f73d533-1e3b-4e36-8bea-6076b9d0a9b5

Set id: 1056d9da-8a3f-4b7a-878e-7f8d45d298cd

Version: 3

Effective Time: 20221103