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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Chest Congestion & Cough

Active ingredient (in each softgel)

Dextromethorphan hydrobromide 10 mg

Guaifenesin 200 mg

Purpose

Cough suppressant

Expectorant

Uses

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

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

Other information

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

CVS Chest Congestion & Cough HBP 20 SOFTGELS

NDC: 51013-406-08

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

Carton Label

CHEST CONGESTION AND COUGH HBP 
dextromethorphan hydrobromide, guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-406
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorred (Clear) Scoreno score
Shapecapsule (Oblong) Size21mm
FlavorImprint Code PC37
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-406-082 in 1 CARTON04/06/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/06/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-406) , analysis(51013-406)

Revised: 1/2020
Document Id: 3680ac72-3552-419c-accb-22eba60b4ae9
Set id: e21305c4-10a5-44c4-a4f9-c303c7872306
Version: 2
Effective Time: 20200103
 
PuraCap Pharmaceutical LLC