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 (20 Tablet Carton Label)

NDC 58602-824-67
Primary Health
COMPARE TO Mucinex® DM
Active ingredients*


Mucus Relief DM
Guaifenesin and
Dextromethorphan HBr
Extended-Release
Tablets 600 mg/30 mg

EXPECTORANT AND
COUGH SUPPRESSANT
      

12 Hour
20 Tablets
Extended-Release Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (20 Tablet Carton Label)

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-824
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:58602-824-672 in 1 CARTON03/17/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-824-084 in 1 CARTON03/17/2017
210 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(58602-824) , MANUFACTURE(58602-824)

Revised: 2/2024
Document Id: 3ff696ea-da6c-4fc6-8cff-9681519ed78d
Set id: 029ee6fb-df76-4df6-b717-70005d5708da
Version: 6
Effective Time: 20240203
 
Aurohealth LLC