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NDC 70000-0452-02 Chest Congestion Relief 400 mg/1 Details

Chest Congestion Relief 400 mg/1

Chest Congestion Relief is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. DBA Leader. 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: 70000-0452-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	70000-0452
Product ID	70000-0452_6148c103-0b27-4a21-99a5-6f13694f432a
Associated GPIs	43200010000340
GCN Sequence Number	051583
GCN Sequence Number Description	guaifenesin TABLET 400 MG ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	18906
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Chest Congestion Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	400
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	Cardinal Health 110, LLC. DBA Leader
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 70000-0452-02 (70000045202)

Pricing Information
NDC Package Code	70000-0452-2
Billing NDC	70000045202
Package	3 BLISTER PACK in 1 CARTON (70000-0452-2) / 8 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2019-03-15
NDC Exclude Flag	N
Price Per Unit	0.063
Pricing Unit	EA
Effective Date	2022-11-23
NDC Description	CHEST CONGEST RLF 400 MG TAB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-11-23

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 92181899-0781-4008-8711-ac722695348f Details

Active ingredient (in each immediate-release tablet)

Guaifenesin 400 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

Ask a doctor before use if you have

cough accompanied by too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

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 (1-800-222-1222) right away.

Directions

take with a full glass of water
adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal display panel

LEADER™

NDC 70000-0452-2

Chest Congestion Relief

Guaifenesin, 400 mg | Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

24 IMMEDIATE-RELEASE TABLETS

Actual Size

100% Money Back Guarantee

50844 ORG011853208

© 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,

the Cardinal Health LOGO, LEADER, and the Leader LOGO are

trademarks or registered trademarks of Cardinal Health.

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Leader 44-532

INGREDIENTS AND APPEARANCE

CHEST CONGESTION RELIEF

guaifenesin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0452
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	blue	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	44;532
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0452-2	3 in 1 CARTON	03/15/2019	09/21/2023
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70000-0452-1	1 in 1 CARTON	03/15/2019	03/23/2022
2		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/15/2019	09/21/2023

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(70000-0452)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(70000-0452)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(70000-0452)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(70000-0452)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(70000-0452)

Revised: 7/2022

Document Id: 6148c103-0b27-4a21-99a5-6f13694f432a

Set id: 92181899-0781-4008-8711-ac722695348f

Version: 8

Effective Time: 20220714