GUAIFENESIN EXTENDED RELEASE 600 MG- guaifenesin tablet, extended release

Guaifenesin Extended Release 600 mg by

Drug Labeling and Warnings

Guaifenesin Extended Release 600 mg by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., 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 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 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?

1-888-287-1915

You may also report side effects to this phone number.

PRINCIPAL DISPLAY PANEL

79903-271-40

equateTM

 

Compare to Mucinex® Extended Release 600mg Tablets active ingredient*

Mucus Relief

 

Guaifenesin Extended-Release Tablets 600mg

 

Expectorant

 

• Relieves chest congestion
• Thins and loosens mucus

 

12 HOUR

Actual Size

600 mg

40 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: 79903-271
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, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
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: 79903-271-40	2 in 1 CARTON	10/22/2024
1		20 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	10/22/2024

Labeler - Wal-Mart Stores, Inc. (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(79903-271)