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 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 or comments?

Call 1-800-632-6900

DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202

MADE IN INDIA

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

NDC 30142-275-14

Kroger®
health

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

MAXIMUM STRENGTH

Mucus Relief DM

Guaifenesin and
Dextromethorphan HBr
Extended-release
Tablets
1,200 mg/60 mg

Expectorant and
Cough Suppressant

12 HOUR

CONTROLS                                        ACTUAL SIZE
COUGH

THINS AND                                         14
LOOSENS MUCUS                             EXTENDED-RELEASE TABLETS

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

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-275
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:30142-275-142 in 1 CARTON05/21/2024
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:30142-275-054 in 1 CARTON05/21/2024
27 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20694105/21/2024
Labeler - KROGER COMPANY (006999528)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(30142-275) , MANUFACTURE(30142-275)

Revised: 5/2024
Document Id: cc97ea77-b7a1-47ee-aa01-ca3305639e9d
Set id: 15b98b7d-2274-450d-e063-6394a90a8d1d
Version: 2
Effective Time: 20240523
 
KROGER COMPANY