GUAIFENESIN - guaifenesin tablet, extended release 
Aurohealth LLC

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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 Blister Carton (100 (5 x 20) Tablets)

NDC 58602-864-98
PrimaryHealth
COMPARE TO
Mucinex®
Active Ingredient*
Guaifenesin
Extended-Release Tablets
600 mg

EXPECTORANT 

12
HOUR

100 
Extended-Release
Tablets

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

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-864
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:58602-864-985 in 1 CARTON03/11/2021
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21045303/11/2021
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-864) , MANUFACTURE(58602-864)

Revised: 12/2023
Document Id: c6c563dc-1026-4eb2-8d38-01d9656ded75
Set id: 30c27274-a051-4884-b41e-12943d92b199
Version: 3
Effective Time: 20231201
 
Aurohealth LLC