MUCUS RELIEF 600 MG - guaifenesin tablet, extended release 
MUCUS RELIEF MAXIMUM STRENGTH 1200 MG - guaifenesin tablet, extended release 
Guardian Drug Company

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Mucus Relief Guaifenesin Extended-Release Tablets 600 mg and 1200 mg

ACTIVE INGREDIENT(in each extended-release tablet)

Guaifenesin 1200 mg

PURPOSE

Expectorant

USE(S)

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNING

.

DO NOT USE

for children under 12 years of age

ASK A DOCTOR BEFORE USE IF YOU HAVE

STOP USE AND A ASK 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 right away (1-800-222-1222).

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number. 

PRINCIPAL DISPLAY PANEL

NDC 53041-191-58

Compare to the active ingredient in Mucinex® Maximum Strength Extended Release 1200 mg Tablets

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Mucus Relief

Guaifenesin Extended-Release Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

14 EXTENDED-RELEASE TABLETS

23414

NDC 53041-191-48

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Mucus Relief

Guaifenesin Extended-Release Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

28 EXTENDED-RELEASE TABLETS


23428


ACTIVE INGREDIENT (in each extended- release tablet)

Guaifenesin 600 mg

PURPOSE

Expectorant

USE(S)

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNING

.

DO NOT USE

ASK A DOCTOR BEFORE USE IF YOU HAVE

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 right away (1-800-222-1222).

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number. 

PRINCIPAL DISPLAY PANEL

NDC 53041-190-32

Compare to the active ingredient in Mucinex® Extended Release 600 mg Tablets

GUARDIAN

12 HOUR

Mucus Relief

Guaifenesin Extended-Release Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

20 EXTENDED-RELEASE TABLETS


23320


NDC 53041-190-20

GUARDIAN

12 HOUR

Mucus Relief

Guaifenesin Extended-Release Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

500 EXTENDED-RELEASE TABLETS

233500


MUCUS RELIEF 600 MG 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-190
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code G233
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-190-322 in 1 CARTON06/24/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:53041-190-384 in 1 CARTON06/24/2020
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:53041-190-16100 in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
4NDC:53041-190-20500 in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20921506/24/2020
MUCUS RELIEF MAXIMUM STRENGTH 1200 MG 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-191
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code G234
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-191-582 in 1 CARTON06/24/2020
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:53041-191-484 in 1 CARTON06/24/2020
27 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:53041-191-3728 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2024
4NDC:53041-191-6270 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20921506/24/2020
Labeler - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(53041-190, 53041-191)

Revised: 4/2024
Document Id: 2ad8b5c2-9495-4ba0-886b-b5f13484aef1
Set id: e7742a43-9066-4e28-a90d-f07c0e18f045
Version: 5
Effective Time: 20240430
 
Guardian Drug Company