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NDC 68084-0572-01 Mucinex 600 mg/1 Details

Mucinex 600 mg/1

Mucinex is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by American Health Packaging. 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: 68084-0572-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	68084-0572
Product ID	68084-572_ea3f438d-b00b-e171-e053-2995a90a32e7
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	Brand
Proprietary Name	Mucinex
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	American Health Packaging
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA021282
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68084-0572-01 (68084057201)

Pricing Information
NDC Package Code	68084-572-01
Billing NDC	68084057201
Package	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-572-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-572-11)
Marketing Start Date	2016-02-10
NDC Exclude Flag	N
Price Per Unit	0.54339
Pricing Unit	EA
Effective Date	2023-12-20
NDC Description	MUCINEX ER 600 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	2
Classification for Rate Setting	B
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 0129f47d-abc2-414c-b4e1-1064c5d6a623 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release bi-layer tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

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.

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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.
store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639) for information about the drug product or to report side effects. For information about packaging, contact American Health Packaging at 1-800-707-4621.

SPL UNCLASSIFIED SECTION

*The name MUCINEX ® and associated trademarked items are used with permission by Reckitt Benckiser

The drug product contained in this package is from NDC # 63824-008 Reckitt Benckiser.

Packaged and Distributed by American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, OH 43217

057201

5500408/0915

Principal Display Panel – Carton – 600 mg

NDC 68084-572-01

Mucinex ®

600 mg guaifenesin

extended-release bi-layer tablets

EXPECTORANT

100 Tablets (10 x 10)

Principal Display Panel – Blister – 600 mg

Mucinex ® (guaifenesin)

EXPECTORANT extended-

release bi-layer tablet 600 mg

INGREDIENTS AND APPEARANCE

MUCINEX

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68084-572(NDC:63824-008)
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 TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white (blue and white)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	Mucinex;600
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68084-572-01	100 in 1 BOX, UNIT-DOSE	02/10/2016
1	NDC:68084-572-11	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021282	02/10/2016

Labeler - American Health Packaging (929561009)

Name	Address	ID/FEI	Business Operations
Establishment
American Health Packaging		929561009	repack(68084-572)

Revised: 10/2022

Document Id: ea3f438d-b00b-e171-e053-2995a90a32e7

Set id: 0129f47d-abc2-414c-b4e1-1064c5d6a623

Version: 5

Effective Time: 20221004

Search by Drug Name or NDC

NDC 68084-0572-01 Mucinex 600 mg/1 Details

Mucinex 600 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68084-0572-01 (68084057201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 0129f47d-abc2-414c-b4e1-1064c5d6a623 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each extended-release bi-layer tablet)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

Principal Display Panel – Carton – 600 mg

Principal Display Panel – Blister – 600 mg

INGREDIENTS AND APPEARANCE

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