GUAIFENESIN - guaifenesin tablet, extended release 
Aurohealth LLC

----------

Drug Facts

Active Ingredient

(in each extended-release tablet)
 Guaifenesin USP 600 mg

Purpose

Expectorant

Uses


Warnings

Do not use


Ask a doctor before use if you have


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 and 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
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablets Label)

Healthy Living

NDC 58602-853-73

Guaifenesin
Extended-Release Tablets 600 mg

EXPECTORANT 

12 HOUR

20 
Extended-Release
Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablet Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablets Carton Label)

Healthy Living
 

NDC 58602-853-73

Compare to the active
ingredient in Mucinex®*

Guaifenesin
Extended-release Tablets 600 mg

EXPECTORANT
 
•Relieves Chest Congestion
•Thins And Loosens Mucus

12 HOUR 

 20
Extended-Release
Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablet Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton (100 (5 x 20) Tablets)

Healthy Living
 

Guaifenesin
extended-release tablets 600 mg


Expectorant
 
•Relieves Chest Congestion
•Thins And Loosens Mucus


12 Hour

*Compare
to the Active
Ingredient in
Mucinex®

100
Extended-Release
Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton (100 (5 x 20) Tablets)

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-853
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
POVIDONE K25 (UNII: K0KQV10C35)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code L;68
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-853-731 in 1 CARTON08/13/2020
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-853-121 in 1 CARTON08/13/2020
240 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-853-211 in 1 CARTON08/13/2020
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-853-961 in 1 CARTON08/13/2020
420 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:58602-853-972 in 1 CARTON08/13/2020
520 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:58602-853-985 in 1 CARTON11/01/2022
620 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21045308/13/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-853) , MANUFACTURE(58602-853)

Revised: 12/2023
Document Id: af251c56-1fce-46a6-bd52-cca3425b96f9
Set id: 84117b6e-4eeb-42b0-90b1-331f70d5a175
Version: 5
Effective Time: 20231201
 
Aurohealth LLC