MUCUS RELIEF- guaifenesin tablet, extended release

Mucus Relief by

Drug Labeling and Warnings

Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. 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 seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing. 
• store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENTS

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

1-800-616-2471

You may also report side effects to this phone number. 

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

• Count: 600 mg
• 12: 71610-499-12
• 60: 71610-499-53

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20201217JH

PRINCIPAL DISPLAY PANEL - 600 mg

NDC: 71610-499 - Guaifenesin ER 600 mg Tablets

INGREDIENTS AND APPEARANCE

MUCUS RELIEF 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71610-499(NDC:0904-6986)
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, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	G233
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71610-499-12	12 in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2021
2	NDC: 71610-499-53	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209215	09/23/2019

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-499)