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NDC 00363-0931-40 Mucus Relief Extended Release 600 mg/1 Details

Mucus Relief Extended Release 600 mg/1

Mucus Relief Extended Release is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. 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: 00363-0931-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	00363-0931
Product ID	0363-0931_1f23481e-89df-4c62-9712-6c9ace91bcbf
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	Mucus Relief Extended Release
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	600
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	Walgreens
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207342
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0931-40 (00363093140)

Pricing Information	N/A
NDC Package Code	0363-0931-40
Billing NDC	00363093140
Package	40 BLISTER PACK in 1 CARTON (0363-0931-40) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	2018-08-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0ea23f92-eda7-49da-bc62-3085dbb4dc0d Details

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes 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 accopanied 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 (1-800-222-1222).

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 tablet every 12 hours. Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use

Other information

store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Mucinex®††

12 HOUR

Mucus Relief ER

GUAIFENESIN EXTENDED-RELEASE TABLETS, 600 MG / EXPECTORANT

12 HOUR

Relieves chest congestion
Thins and loosens mucus

EXTENDED-RELEASE TABLETS

††This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Mucinex®.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Package Label

WALGREENS Mucus Relief ER

INGREDIENTS AND APPEARANCE

MUCUS RELIEF EXTENDED RELEASE

guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0931
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 934 (UNII: Z135WT9208)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	AN036
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0931-40	40 in 1 CARTON	08/31/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0363-0931-20	20 in 1 CARTON	08/31/2018
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0363-0931-10	100 in 1 CARTON	08/31/2018
3		1 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
ANDA	ANDA207342	08/31/2018

Labeler - Walgreens (008965063)

Revised: 5/2022

Document Id: 1f23481e-89df-4c62-9712-6c9ace91bcbf

Set id: 0ea23f92-eda7-49da-bc62-3085dbb4dc0d

Version: 5

Effective Time: 20220526