GUAIFENESIN - guaifenesin tablet, extended release 
Aurohealth LLC

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Drug Facts

Active ingredient

(in each extended-release tablet)

Guaifenesin USP 1200 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 - 1200 mg Blister Carton (42 (3 x 14) Tablets)

NDC 58602-865-03
PrimaryHealth

COMPARE TO Maximum
Strength Mucinex®
Active Ingredient*

MAXIMUM STRENGTH

Guaifenesin
Extended-Release Tablets
1200 mg
EXPECTORANT

12
HOUR

42
Extended-Release
Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (42 (3 x 14) Tablets)

GUAIFENESIN 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-865
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 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
ShapeOVALSize21mm
FlavorImprint Code L;69
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-865-033 in 1 CARTON03/11/2021
114 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(58602-865) , MANUFACTURE(58602-865)

Revised: 12/2023
Document Id: 42a46a38-1d5a-4fbe-99a3-8bdb05ed16e2
Set id: 4ec1477e-6e33-4c40-a476-cf7f4f00192b
Version: 3
Effective Time: 20231201
 
Aurohealth LLC