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NDC 70000-0479-01 Mucus Relief Extended Release 1200 mg/1 Details

Mucus Relief Extended Release 1200 mg/1

Mucus Relief Extended Release is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. 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: 70000-0479-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	70000-0479
Product ID	70000-0479_5a6297be-3167-4cd2-80c7-b1a62fdbce54
Associated GPIs	43200010007450
GCN Sequence Number	063103
GCN Sequence Number Description	guaifenesin TAB ER 12H 1200 MG ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	98863
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Mucus Relief Extended Release
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	1200
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	Cardinal Health (Leader) 70000
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 70000-0479-01 (70000047901)

Pricing Information
NDC Package Code	70000-0479-1
Billing NDC	70000047901
Package	14 BLISTER PACK in 1 CARTON (70000-0479-1) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	2019-01-31
NDC Exclude Flag	N
Price Per Unit	0.46903
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	MUCUS RELIEF ER 1,200 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 54a59e95-f95a-4bcd-ac9d-8d4ace85277f 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 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 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 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 MUCINEX® MAXIMUM STRENGTH active ingredient*

Maximum Strength

Mucus Relief

Guaifenesin, 1200 mg | Expectorant

12-Hour Relief

Relieves Chest Congestion

Thins and Loosens Mucus

EXTENDED-RELEASE TABLETS

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Maximum Strength 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 CARDINAL HEALTH

DUBLIN OHIO 43017

www.myleader.com

Package Label

LEADER Maximum Strength Mucus Relief

INGREDIENTS AND APPEARANCE

MUCUS RELIEF EXTENDED RELEASE MAXIMUM STRENGTH

guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0479
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARBOMER 934 (UNII: Z135WT9208)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	AN037
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0479-1	14 in 1 CARTON	01/31/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70000-0479-2	28 in 1 CARTON	01/31/2019
2		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	01/31/2019

Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2022

Document Id: 5a6297be-3167-4cd2-80c7-b1a62fdbce54

Set id: 54a59e95-f95a-4bcd-ac9d-8d4ace85277f

Version: 5

Effective Time: 20221020