GUAIFENESIN AND DEXTROMETHORPHAN HBR - guaifenesin and dextromethorphan hbr tablet, extended release 
Aurohealth LLC

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Drug Facts

Active ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg

Purpose

Cough suppressant
Expectorant

Uses


Warnings


Do not use

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 (1-800-222-1222) right away.

Directions


Other information


Inactive ingredients


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

Questions?


call 1-855-274-4122  You may also report side effects to this phone number.

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

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg 14 (2 x 7) Tablets Carton Label

Healthy Living™

NDC 58602-849-65
Compare to the active ingredients of
Maximum Strength Mucinex® DM*

MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets 1200 mg/60 mg

EXPECTORANT AND
COUGH SUPPRESSANT

Controls Cough
Thins and Loosens Mucus

12
HOUR

63
14 (2 x 7) Extended-release Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg 14 (2 x 7) Tablets Carton Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (60 Tablet Container Label)

Healthy Living™

NDC 58602-849-15

MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets 1200 mg/60 mg

EXPECTORANT AND
COUGH SUPPRESSANT

Controls Cough
Thins and Loosens Mucus

12
HOUR

63
60 Extended-release Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (60 Tablet Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (60 Tablet Container Carton)

Healthy Living™

NDC 58602-849-15
Compare to the active ingredients of
Maximum Strength Mucinex® DM*

MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets 1200 mg/60 mg

EXPECTORANT AND
COUGH SUPPRESSANT

Controls Cough
Thins and Loosens Mucus

12
HOUR

63
60 Extended-release Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton (60 Tablets)

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-849
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
POVIDONE K25 (UNII: K0KQV10C35)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code X;63
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-849-652 in 1 CARTON05/16/2020
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-849-118 in 1 CARTON08/13/2020
27 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:58602-849-151 in 1 CARTON08/13/2020
360 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-849-571 in 1 CARTON09/08/2020
428 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-849-641 in 1 CARTON02/24/2021
57 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20694105/16/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-849) , MANUFACTURE(58602-849)

Revised: 12/2023
Document Id: 4527c967-25f5-463f-a07d-655e9149e8b7
Set id: 88bc399a-2b71-45a7-bdfb-226ff1df0536
Version: 7
Effective Time: 20231204
 
Aurohealth LLC