PSEUDOEPHEDRINE HCL - pseudoephedrine hcl tablet, extended release 
Aurohealth LLC

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Pseudoephedrine HCl Extended-Release Tablets USP 120 mg

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl USP 120 mg

Purpose

Nasal decongestant

Uses

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

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

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

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


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

PSEUDOEPHEDRINE HCL 
pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-804
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (White to Off-white) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 70;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-804-831 in 1 CARTON06/09/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-804-672 in 1 CARTON06/09/2017
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20900806/09/2017
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(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
 
Aurohealth LLC