GUAIFENESIN AND DEXTROMETHORPHAN HBR - guaifenesin and dextromethorphan hbr tablet, extended release 
KROGER COMPANY

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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 or comments?


Call 1-800-632-6900

DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202

MADE IN INDIA
 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (40 Tablets Blister Carton Label)

NDC 30142-276-40

Kroger®
health

COMPARE TO THE ACTIVE INGREDIENTS IN
MUCINEX® DM EXTENDED-RELEASE
BI-LAYER TABLETS*

Mucus Relief DM
Guaifenesin and
Dextromethorphan HBr
Extended-release
Tablets 6
00 mg/30 mg

Expectorant and
Cough Suppressant

12 HOUR

CONTROLS                                        ACTUAL SIZE
COUGH

THINS AND                                         40
LOOSENS MUCUS                             EXTENDED-RELEASE TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (40 Tablet Carton Label)

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-276
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:30142-276-202 in 1 CARTON05/27/2024
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:30142-276-404 in 1 CARTON05/27/2024
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20694105/27/2024
Labeler - KROGER COMPANY (006999528)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(30142-276) , MANUFACTURE(30142-276)

Revised: 5/2024
Document Id: 706164e2-9585-464f-898a-8ca932037fb1
Set id: 15e54152-dc82-6442-e063-6294a90a8541
Version: 2
Effective Time: 20240529
 
KROGER COMPANY