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

Guaifenesin Extended-Release 1200 mg by

Drug Labeling and Warnings

Guaifenesin Extended-Release 1200 mg by is a Otc medication manufactured, distributed, or labeled by Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema 
• cough accompanied by too much phlegm (mucus)

STOP USE AND A ASK DOCTOR IF

•  cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. 

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

• do not crush, chew, or break tablet
• take with a full glass of water
• this product can be administered without regard for the timing of meals
• adults and children 12 years of age and over: 1 or 2 tablets every 12 hours.  
• Do not exceed 4 tablets in 24 hours.
• children under 12 years of age: do not use

OTHER INFORMATION

• tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
• store between 20 to 25°C (68 to 77°F)

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

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

STOP USE AND ASK A DOCTOR IF

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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

• do not crush, chew, or break tablet
• take with a full glass of water
• this product can be administered without regard for the timing of meals
• adults and children 12 years of age and over: 1 tablet every 12 hours.  
• Do not exceed 2 tablets in 24 hours.
• children under 12 years of age: do not use

OTHER INFORMATION

• tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
• store between 20 to 25°C (68 to 77°F)

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

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

INGREDIENTS AND APPEARANCE

GUAIFENESIN EXTENDED-RELEASE 600 MG 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53041-233
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	G233
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53041-233-32	2 in 1 CARTON	03/01/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 53041-233-30	1 in 1 CARTON	03/01/2018
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 53041-233-38	4 in 1 CARTON	03/01/2018
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209215	03/01/2018

GUAIFENESIN EXTENDED-RELEASE 1200 MG 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53041-234
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	G234
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53041-234-58	2 in 1 CARTON	03/01/2018
1		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 53041-234-37	4 in 1 CARTON	03/01/2018
2		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 53041-234-47	6 in 1 CARTON	03/01/2018
3		7 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209215	03/01/2018

Labeler - Guardian Drug Company (119210276)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(53041-233, 53041-234)