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NDC 63187-0954-20 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 Proficient Rx LP. 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: 63187-0954-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63187-0954
Product ID	63187-954_d8381687-e02a-45ea-8a85-8c84874cf919
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	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	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA021282
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0954-20 (63187095420)

Pricing Information	N/A
NDC Package Code	63187-954-20
Billing NDC	63187095420
Package	20 TABLET, EXTENDED RELEASE in 1 CARTON (63187-954-20)
Marketing Start Date	2019-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f3ade814-2759-4ad0-a196-210e84d8cde9 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

•: Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
•: 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)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser

Parsippany, NJ 07054-0224

Relabeled by: Proficient Rx LP

Thousand Oaks, CA 91320

Made in England

PRINCIPAL DISPLAY PANEL - 40 Tablet Carton

NDC 63187-954-20

Mucinex®

600 mg guaifenesin

extended-release bi-layer tablets

EXPECTORANT

12

HOUR

•: Relieves Chest Congestion
•: Thins and Loosens Mucus
•: Immediate and Extended Release

20

EXTENDED-RELEASE

BI-LAYER TABLETS

INGREDIENTS AND APPEARANCE

MUCINEX

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-954(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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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:63187-954-20	20 in 1 CARTON; Type 0: Not a Combination Product	08/01/2019
2	NDC:63187-954-40	40 in 1 CARTON; Type 0: Not a Combination Product	01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021282	07/03/2012

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(63187-954)

Revised: 1/2021

Document Id: d8381687-e02a-45ea-8a85-8c84874cf919

Set id: f3ade814-2759-4ad0-a196-210e84d8cde9

Version: 4

Effective Time: 20210101

Search by Drug Name or NDC

NDC 63187-0954-20 Mucinex 600 mg/1 Details

Mucinex 600 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63187-0954-20 (63187095420)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f3ade814-2759-4ad0-a196-210e84d8cde9 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 - 40 Tablet Carton

INGREDIENTS AND APPEARANCE

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