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NDC 63824-0023-02 Mucinex 1200 mg/1 Details

Mucinex 1200 mg/1

Mucinex 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.

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: 63824-0023-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63824-0023
Product ID	63824-023_3749160e-0e3b-4c6c-8f36-d9fc7311f78f
Associated GPIs	43200010007450
GCN Sequence Number	063103
GCN Sequence Number Description	guaifenesin TAB ER 12H 1200 MG ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	98863
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Brand
Proprietary Name	Mucinex
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	1200
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	RB Health (US) LLC
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 63824-0023-02 (63824002302)

Pricing Information	N/A
NDC Package Code	63824-023-02
Billing NDC	63824002302
Package	1 POUCH in 1 CARTON (63824-023-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCH
Marketing Start Date	2021-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 47f5323c-ee3a-400d-b133-31d9c286fafd Details

SPL UNCLASSIFIED SECTION

Drug Facts

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

Guaifenesin 1200 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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
children under 12 years of age: do not use

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C blue no. 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: RB Health (US)

Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

NDC 63824-023-35

MAXIMUM STRENGTH

Mucinex®

1200 mg guaifenesin

extended-release bi-layer tablets

EXPECTORANT

12

HOUR®

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

14

EXTENDED-RELEASE

BI-LAYER TABLETS

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

MUCINEX MAXIMUM STRENGTH

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-023
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	1200 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)

Product Characteristics
Color	WHITE (blue and white)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	Mucinex;1200
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-023-07	1 in 1 CARTON	06/11/2015
1		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:63824-023-35	1 in 1 CARTON	06/26/2012
2		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:63824-023-36	2 in 1 CARTON	06/26/2012
3		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:63824-023-48	4 in 1 CARTON	06/26/2012
4		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:63824-023-46	3 in 1 CARTON	06/26/2012
5		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:63824-023-18	2 in 1 CARTON	06/26/2012	06/15/2022
6		9 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC:63824-023-02	1 in 1 CARTON	07/01/2021
7		1 in 1 POUCH; Type 0: Not a Combination Product
8	NDC:63824-023-56	4 in 1 CARTON	07/01/2021
8		14 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	06/26/2012

Labeler - RB Health (US) LLC (081049410)

Revised: 6/2022

Document Id: 3749160e-0e3b-4c6c-8f36-d9fc7311f78f

Set id: 47f5323c-ee3a-400d-b133-31d9c286fafd

Version: 13

Effective Time: 20220616

Search by Drug Name or NDC

NDC 63824-0023-02 Mucinex 1200 mg/1 Details

Mucinex 1200 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63824-0023-02 (63824002302)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 47f5323c-ee3a-400d-b133-31d9c286fafd 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 - 14 Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

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