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.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Bottle)

NDC 58602-715-05
MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

Compare to the active ingredients of
Maximum Strength Mucinex® DM*
NDC 58602-715-05
Mucus Relief DM
MAXIMUM STRENGTH
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets

Comparative to the active ingredients of
Maximum Strength Mucinex® DM*
NDC 58602-715-70
MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and
Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
28 (4 x7)
Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-715
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:58602-715-051 in 1 CARTON03/17/2017
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-715-571 in 1 CARTON03/17/2017
228 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-715-091 in 1 CARTON03/17/2017
330 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-715-681 in 1 CARTON03/17/2017
438 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-715-601 in 1 CARTON03/17/2017
542 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-715-691 in 1 CARTON03/17/2017
644 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:58602-715-151 in 1 CARTON03/17/2017
760 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:58602-715-704 in 1 CARTON03/17/2017
87 in 1 BLISTER PACK; Type 0: Not a Combination Product
9NDC:58602-715-066 in 1 CARTON03/17/2017
97 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC:58602-715-652 in 1 CARTON03/17/2017
107 in 1 BLISTER PACK; Type 0: Not a Combination Product
11NDC:58602-715-106 in 1 CARTON03/17/2017
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
12NDC:58602-715-641 in 1 CARTON03/17/2017
127 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(58602-715) , MANUFACTURE(58602-715)

Revised: 2/2024
Document Id: fc29833f-bf1b-4e9a-88d1-5ef90db55170
Set id: d0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b7
Version: 11
Effective Time: 20240203
 
Aurohealth LLC