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NDC 63629-7886-01 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 Bryant Ranch Prepack. 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: 63629-7886-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63629-7886
Product ID	63629-7886_7cb68a50-16dc-460f-a47c-a146840c6c5d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Bryant Ranch Prepack
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	2023-12-31

Package

Package Images

NDC 63629-7886-01 (63629788601)

Pricing Information	N/A
NDC Package Code	63629-7886-1
Billing NDC	63629788601
Package	20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (63629-7886-1)
Marketing Start Date	2019-06-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8c67e0a-1f2c-4e96-91fe-0d90546d8b1b 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

store at 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: RB Health (US)

Parsippany, NJ 07054-0224

Made in England

HOW SUPPLIED

NDC: 63629-7886-1: 20 Tablets in a BLISTER PACK

NDC: 63629-7886-2: 40 Tablets in a BLISTER PACK

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCINEX

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-7886(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:63629-7886-1	20 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/13/2019
2	NDC:63629-7886-2	40 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/01/2022

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

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-7886) , RELABEL(63629-7886)

Revised: 9/2022

Document Id: 7cb68a50-16dc-460f-a47c-a146840c6c5d

Set id: a8c67e0a-1f2c-4e96-91fe-0d90546d8b1b

Version: 6

Effective Time: 20220901

Search by Drug Name or NDC

NDC 63629-7886-01 Mucinex 600 mg/1 Details

Mucinex 600 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63629-7886-01 (63629788601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a8c67e0a-1f2c-4e96-91fe-0d90546d8b1b 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

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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