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NDC 69842-0014-08 Chest Congestion and Cough HBP 10; 200 mg/1; mg/1 Details

Chest Congestion and Cough HBP 10; 200 mg/1; mg/1

Chest Congestion and Cough HBP is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY, INC.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 69842-0014-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

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: 69842-0014-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	69842-0014
Product ID	69842-014_92c1171e-08f2-492e-ae7b-d45efce0bbf4
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	Chest Congestion and Cough HBP
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan hydrobromide, Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	10; 200
Active Ingredient Units	mg/1; mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	CVS PHARMACY, INC.
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0014-08 (69842001408)

Pricing Information	N/A
NDC Package Code	69842-014-08
Billing NDC	69842001408
Package	2 BLISTER PACK in 1 CARTON (69842-014-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2017-04-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1a00bd38-496c-44ed-823f-2c9cc98f0305 Details

Active ingredient (in each softgel)

Dextromethorphan hydrobromide 10 mg

Guaifenesin 200 mg

Purpose

Cough suppressant

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

cough that occurs with excessive phlegm (mucus)
persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with 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 right away. Abuse of this product can lead to serious injury.

Directions

do not exceed recommended dose
adults and children 12 years and over:

1 or 2 softgels every 4 hours, not more than 12 softgels in 24 hours

children under 12 years of age: ask a doctor

Other information

store at room temperature 15-30°C (59-86°F)
avoid excessive heat above 40°C (104°F)

Inactive ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white ink

Questions or comments

Call toll free: 1-855-215-8180

Principal Display Panel - Carton Label

CVS Chest Congestion & Cough HBP 20 SOFTGELS

NDC: 69842-014-08

*Compare to the active ingredients in Coricidin® HBP Chest Congestion & Cough

INGREDIENTS AND APPEARANCE

CHEST CONGESTION AND COUGH HBP

dextromethorphan hydrobromide, guaifenesin capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-014
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red (Clear)	Score	no score
Shape	capsule (Oblong)	Size	21mm
Flavor		Imprint Code	PC37
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-014-08	2 in 1 CARTON	04/13/2017
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
OTC monograph final	part341	04/13/2017

Labeler - CVS PHARMACY, INC. (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(69842-014) , analysis(69842-014)

Revised: 11/2019

Document Id: 92c1171e-08f2-492e-ae7b-d45efce0bbf4

Set id: 1a00bd38-496c-44ed-823f-2c9cc98f0305

Version: 3

Effective Time: 20191121