GUAIFENESIN AND PSEUDOEPHEDRINE HCL - guaifenesin and pseudoephedrine hcl tablet, extended release 
Aurohealth LLC

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Drug Facts

Active ingredients

(in each extended-release tablet)     

Guaifenesin USP 1200 mg                                                                                      

Pseudoephedrine HCl USP 120 mg                                                                        

Purposes

Expectorant

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

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

Other information

Inactive ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.


Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India
Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg/120 mg (12 Tablet Carton Label)

AUROHEALTH

NDC 58602-834-77

*Compare to the active
Ingredients of Mucinex®D

MAXIMUM STRENGTH

Guaifenesin and
Pseudoephedrine Hydrochloride
Extended-Release Tablets
1200 mg/120 mg


EXPECTORANT & NASAL DECONGESTANT

12 HOUR
• Clears Nasal/Sinus Congestion
• Thins And Loosens Mucus

12 Extended-Release Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/60 mg (18 Tablet Carton Label)

GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-834
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POVIDONE K25 (UNII: K0KQV10C35)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeCAPSULE (modified, biconvex) Size22mm
FlavorImprint Code 65;X
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-834-771 in 1 CARTON03/25/2020
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-834-782 in 1 CARTON03/25/2020
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21320303/25/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-834) , MANUFACTURE(58602-834)

Revised: 11/2023
Document Id: 155630ff-fa82-449a-a485-2891c60e25d8
Set id: 2f622f57-4de0-44a9-a21f-c98260574f1e
Version: 3
Effective Time: 20231129
 
Aurohealth LLC