GUAIFENESIN EXTENDED-RELEASE 600 MG - guaifenesin tablet, extended release 
GUAIFENESIN EXTENDED-RELEASE 1200 MG - guaifenesin tablet, extended release 
Guardian Drug Company

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Guaifenesin Extended Release Tablets 600 mg and 1200 mg

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

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.

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

WARNINGS

.

DO NOT USE

for children under 12 years of age

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 600 MG

NDC 53041-233-32

GUARDIAN

12 HOUR

Guaifenesin

Extended-Release

Tablets 600 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

20 EXTENDED-RELEASE TABLETS

600

PRINCIPAL DISPLAY PANEL 1200 MG

NDC 53041-234-58

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Guaifenesin

Extended-Release

Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucuc

14 EXTENDED-RELEASE TABLETS

1200

GUAIFENESIN EXTENDED-RELEASE 600 MG 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-233
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 TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code G233
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-233-322 in 1 CARTON03/01/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:53041-233-301 in 1 CARTON03/01/2018
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:53041-233-384 in 1 CARTON03/01/2018
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20921503/01/2018
GUAIFENESIN EXTENDED-RELEASE 1200 MG 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-234
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 TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code G234
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-234-582 in 1 CARTON03/01/2018
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:53041-234-374 in 1 CARTON03/01/2018
27 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:53041-234-476 in 1 CARTON03/01/2018
37 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20921503/01/2018
Labeler - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(53041-233, 53041-234)

Revised: 2/2018
Document Id: 8186c3e8-1ae5-459d-8771-ad2d1ae95387
Set id: 20f9e083-419d-429d-a570-24b312ed5d2a
Version: 2
Effective Time: 20180228
 
Guardian Drug Company