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NDC 63824-0057-18 Mucinex D 600; 60 mg/1; mg/1 Details

Mucinex D 600; 60 mg/1; mg/1

Mucinex D is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE.

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: 63824-0057-18
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Related Packages: 63824-0057-18
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	63824-0057
Product ID	63824-057_a528a930-5a3c-4f9d-85ce-2d560f04b5ca
Associated GPIs	43996202307435
GCN Sequence Number	012073
GCN Sequence Number Description	guaifenesin/pseudoephedrne HCl TAB ER 12H 600MG-60MG ORAL
HIC3	B4W
HIC3 Description	DECONGESTANT-EXPECTORANT COMBINATIONS
GCN	54980
HICL Sequence Number	000270
HICL Sequence Number Description	GUAIFENESIN/PSEUDOEPHEDRINE HCL
Brand/Generic	Brand
Proprietary Name	Mucinex D
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin and Pseudoephedrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	600; 60
Active Ingredient Units	mg/1; mg/1
Substance Name	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA021585
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63824-0057-18 (63824005718)

Pricing Information
NDC Package Code	63824-057-18
Billing NDC	63824005718
Package	1 BLISTER PACK in 1 CARTON (63824-057-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2012-06-26
NDC Exclude Flag	N
Price Per Unit	0.70353
Pricing Unit	EA
Effective Date	2024-01-17
NDC Description	MUCINEX D ER 600-60 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 d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each extended-release bi-layer tablet)	Purposes
Guaifenesin 600 mg	Expectorant
Pseudoephedrine HCl 60 mg	Nasal Decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
temporarily relieves sinus congestion and pressure

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

When using this product

do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days, come back or occur with a 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 timing of meals
adults and children 12 years and older: 2 tablets every 12 hours; not more than 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 at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C yellow #6 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: RB Health (US)

Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 18 Tablet Carton

NDC 63824-057-18

Mucinex®D

600 mg guaifenesin & 60 mg pseudoephedrine HCl

extended-release bi-layer tablets

EXPECTORANT

& NASAL DECONGESTANT

12

HOUR

✓: Clears Nasal/Sinus Congestion
✓: Thins and Loosens Mucus
✓: Immediate and Extended Release

18

EXTENDED-RELEASE

BI-LAYER TABLETS

PRINCIPAL DISPLAY PANEL - 18 Tablet Carton

INGREDIENTS AND APPEARANCE

MUCINEX D

guaifenesin and pseudoephedrine hydrochloride tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-057
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	600 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	60 mg

Ingredient Name	Strength
Inactive Ingredients
carbomer homopolymer type B (allyl pentaerythritol crosslinked) (UNII: HHT01ZNK31)
FD&C yellow NO. 6 (UNII: H77VEI93A8)
aluminum oxide (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	ORANGE, WHITE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	Mucinex;600
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63824-057-18	1 in 1 CARTON	06/26/2012
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:63824-057-36	4 in 1 CARTON	06/26/2012
2		9 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	NDA021585	06/26/2012

Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022

Document Id: a528a930-5a3c-4f9d-85ce-2d560f04b5ca

Set id: d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f

Version: 8

Effective Time: 20220111

Search by Drug Name or NDC

NDC 63824-0057-18 Mucinex D 600; 60 mg/1; mg/1 Details

Mucinex D 600; 60 mg/1; mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63824-0057-18 (63824005718)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 18 Tablet Carton

INGREDIENTS AND APPEARANCE

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