Search by Drug Name or NDC

NDC 71610-0499-12 Mucus Relief 600 mg/1 Details

Mucus Relief 600 mg/1

Mucus Relief is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is GUAIFENESIN.

MedlinePlus Drug Summary

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 71610-0499-12
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	71610-0499
Product ID	71610-499_349de2f9-ec60-43d7-990a-074c673aa7e3
Associated GPIs	43200010007420
GCN Sequence Number	071885
GCN Sequence Number Description	guaifenesin TAB ER 12H 600 MG ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	35905
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Mucus Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	600
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209215
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71610-0499-12 (71610049912)

Pricing Information	N/A
NDC Package Code	71610-499-12
Billing NDC	71610049912
Package	12 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-12)
Marketing Start Date	2021-04-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 01af03f1-5d1b-4893-b7db-7092ba66e842 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209215	09/23/2019

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

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

Revised: 5/2021

Document Id: 349de2f9-ec60-43d7-990a-074c673aa7e3

Set id: 01af03f1-5d1b-4893-b7db-7092ba66e842

Version: 2

Effective Time: 20210503