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NDC 00113-3650-74 Good Sense Mucus ER 1200 mg/1 Details

Good Sense Mucus ER 1200 mg/1

Good Sense Mucus ER is a ORAL TABLET, MULTILAYER, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo 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: 00113-3650-74
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	00113-3650
Product ID	0113-3650_159d4955-7b43-442f-9d80-918cc7f6546b
Associated GPIs	43200010007450
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	Good Sense Mucus ER
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, MULTILAYER, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	1200
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	L. Perrigo Company
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA213420
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00113-3650-74 (00113365074)

Pricing Information	N/A
NDC Package Code	0113-3650-74
Billing NDC	00113365074
Package	1 BLISTER PACK in 1 CARTON (0113-3650-74) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2021-03-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 49de9c3b-9840-4fc2-988f-4361de6aa3c1 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)

Inactive ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

GOODSENSE®

12 Hour

Maximum Strength

Mucus•ER

Guaifenesin Extended-Release Tablets, 1200 mg

Actual Size

Expectorant

• Relieves Chest Congestion

• Thins and Loosens Mucus

• Immediate and Extended Release

Compare to active ingredient of Maximum Strength Mucinex®

BONUS SIZE 7 + 7 Tablets FREE

14 Extended-Release Tablets

INGREDIENTS AND APPEARANCE

GOOD SENSE MUCUS ER

guaifenesin tablet, multilayer, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-3650
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 OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	G;1200
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0113-3650-74	1 in 1 CARTON	03/20/2021
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0113-3650-01	2 in 1 CARTON	09/09/2021
2		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0113-3650-00	1 in 1 CARTON	03/31/2022
3		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0113-3650-10	7 in 1 CARTON	05/05/2022
4		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	ANDA213420	03/20/2021

Labeler - L. Perrigo Company (006013346)

Revised: 5/2022

Document Id: 159d4955-7b43-442f-9d80-918cc7f6546b

Set id: 49de9c3b-9840-4fc2-988f-4361de6aa3c1

Version: 4

Effective Time: 20220505