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 30 mg
Guaifenesin USP 600 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. 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Bottle)

NDC 58602-714-05
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
600 mg/30 mg
EXPECTORANT AND COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Carton Label)

Compare to the active
ingredients of Mucinex® DM*
NDC 58602-714-05
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
600 mg/30 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg Blister Carton 20 (2 x 10) Unit-dose Tablets

Compare to the active
ingredients of Mucinex® DM*
NDC 58602-714-67
Mucus Relief DM
Guaifenesin and
Dextromethorphan HBr
Extended-release Tablets
600 mg/30 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
20 (2 x 10) Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg Blister Carton 20 (2 x 10) Unit-dose Tablets

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-714
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 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
ShapeOVALSize16mm
FlavorImprint Code X;62
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-714-051 in 1 CARTON03/17/2017
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-714-731 in 1 CARTON03/17/2017
220 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-714-091 in 1 CARTON03/17/2017
330 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-714-121 in 1 CARTON03/17/2017
440 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-714-661 in 1 CARTON03/17/2017
558 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-714-151 in 1 CARTON03/17/2017
660 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:58602-714-672 in 1 CARTON03/17/2017
7NDC:58602-714-0310 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:58602-714-084 in 1 CARTON03/17/2017
8NDC:58602-714-0310 in 1 BLISTER PACK; Type 0: Not a Combination Product
9NDC:58602-714-076 in 1 CARTON03/17/2017
9NDC:58602-714-0310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20694103/17/2017
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-714) , MANUFACTURE(58602-714)

Revised: 2/2024
Document Id: 5a5389eb-635c-4831-9ba7-4e037b42cec5
Set id: cc20129b-2556-4452-9222-afd503f1e7a4
Version: 11
Effective Time: 20240203
 
Aurohealth LLC