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NDC 62011-0382-01 Guaifenesin Extended Release 600 mg 600 mg/1 Details

Guaifenesin Extended Release 600 mg 600 mg/1

Guaifenesin Extended Release 600 mg is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services 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: 62011-0382-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	62011-0382
Product ID	62011-0382_bd3e14ab-7aa6-4646-a757-17aa99ee71e7
Associated GPIs	43200010007420
GCN Sequence Number	071885
GCN Sequence Number Description	guaifenesin TAB ER 12H 600 MG ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	35905
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Guaifenesin Extended Release 600 mg
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	Strategic Sourcing Services LLC
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209215
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62011-0382-01 (62011038201)

Pricing Information
NDC Package Code	62011-0382-1
Billing NDC	62011038201
Package	4 BLISTER PACK in 1 CARTON (62011-0382-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2019-10-17
NDC Exclude Flag	N
Price Per Unit	0.32501
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	HM MUCUS RELIEF ER 600 MG TAB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL d2c4ea2f-dbdc-40e1-96df-a0193560e9ea Details

ACTIVE INGREDIENT(in each extended-release tablet)

Guaifenesin 600 mg

PURPOSE

Expectorant

USE(S)

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNING

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 A ASK 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 to 2 tablets every 12 hours.
Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use

OTHER INFORMATION

tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENTS

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

PRINCIPAL DISPLAY PANEL

NDC 62011-0382-1

HealthMart

Compare to Mucinex Extended Release 600mg Tablets Active Ingredient*

12 HOUR

Mucus Relief

Guaifenesin Extended-Release Tablets 600 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

40 EXTENDED-RELEASE TABLETS

INGREDIENTS AND APPEARANCE

GUAIFENESIN EXTENDED RELEASE 600 MG

guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62011-0382
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)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	G233
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62011-0382-1	4 in 1 CARTON	10/17/2019
1		10 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	ANDA209215	10/17/2019

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 1/2022

Document Id: bd3e14ab-7aa6-4646-a757-17aa99ee71e7

Set id: d2c4ea2f-dbdc-40e1-96df-a0193560e9ea

Version: 5

Effective Time: 20220106