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NDC 00363-0325-66 mucus relief er 1200 mg/1 Details

mucus relief er 1200 mg/1

mucus relief er is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-0325-66
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	00363-0325
Product ID	0363-0325_badff197-4e13-4ff7-96c4-85dcbacd51cb
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 er
Proprietary Name Suffix	n/a
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	Walgreen Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA091009
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00363-0325-66 (00363032566)

Pricing Information	N/A
NDC Package Code	0363-0325-66
Billing NDC	00363032566
Package	1 BOTTLE in 1 CARTON (0363-0325-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date	2016-03-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 285b0e59-9a54-45a1-b2bf-454f038fff1c Details

Active ingredient (in each extended-release 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 (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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
•: children under 12 years of age: do not use

Other information

•: store between 20°-25°C (68°-77°F)
•: do not use if printed foil under cap is broken or missing

Inactive ingredients

colloidal silicon dioxide, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate Type A, stearic acid

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Maximum Strength Mucinex® active ingredient

12 HOUR

Mucus Relief ER

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg / EXPECTORANT

MAXIMUM STRENGTH

12 HOUR

Relieves chest congestion

Thins & loosens mucus

28 EXTENDED-RELEASE TABLETS

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

MUCUS RELIEF ER

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0325
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	OVAL (Biconvex)	Size	22mm
Flavor		Imprint Code	Watson;1200
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0325-66	1 in 1 CARTON	03/18/2016
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0363-0325-30	1 in 1 CARTON	03/18/2016
2		28 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091009	03/18/2016

Labeler - Walgreen Company (008965063)

Revised: 1/2019

Document Id: badff197-4e13-4ff7-96c4-85dcbacd51cb

Set id: 285b0e59-9a54-45a1-b2bf-454f038fff1c

Version: 3

Effective Time: 20190114