CHEST CONGESTION AND COUGH HBP- dextromethorphan hydrobromide, guaifenesin capsule, liquid filled

Chest Congestion and Cough HBP by

Drug Labeling and Warnings

Chest Congestion and Cough HBP by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC., Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/13/2017

Labeler - CVS PHARMACY, INC. (062312574)

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