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NDC 67544-0149-70 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 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: 67544-0149-70
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	67544-0149
Product ID	67544-149_cc734890-e42c-454a-b771-3ecd169d161a
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	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA021282
Listing Certified Through	2024-12-31

Package

Package Images

NDC 67544-0149-70 (67544014970)

Pricing Information	N/A
NDC Package Code	67544-149-70
Billing NDC	67544014970
Package	120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-70)
Marketing Start Date	2012-08-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1c84bf00-ebaa-4e69-a2c6-716631d209d9 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

Made in England

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
60	67544-149-53
120	67544-149-70
180	67544-149-80

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

20171218DKJ

PRINCIPAL DISPLAY PANEL - 600mg

NDC 67544-149 Guaifenesin (Mucinex) ER 600mg - Rx Only

INGREDIENTS AND APPEARANCE

MUCINEX

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67544-149(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)
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:67544-149-53	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2012
2	NDC:67544-149-70	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/22/2012
3	NDC:67544-149-80	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/12/2012

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(67544-149)

Revised: 12/2017

Document Id: cc734890-e42c-454a-b771-3ecd169d161a

Set id: 1c84bf00-ebaa-4e69-a2c6-716631d209d9

Version: 1

Effective Time: 20171218

Search by Drug Name or NDC

NDC 67544-0149-70 Mucinex 600 mg/1 Details

Mucinex 600 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 67544-0149-70 (67544014970)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1c84bf00-ebaa-4e69-a2c6-716631d209d9 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

Repackaging Information

PRINCIPAL DISPLAY PANEL - 600mg

INGREDIENTS AND APPEARANCE

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