COUGH RELIEF- dextromethorphan hydrobromide capsule, liquid filled 
Chain Drug Marketing Association Inc.

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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Long-Lasting Cough Relief 

Drug Facts

Active ingredient (in each softgel)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant 

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

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

  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by 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.

Directions

age

     dose

adults and children 12 years and over

     take 2 softgels every 6 to 8 hours, as needed

children under 12 years

     do not use

Other information

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions or comments?

Call toll free: 248-449-9300

PRINCIPAL DISPLAY PANEL

ADULT LONG-LASTING Cough Relief

Dextromethorphan HBr, USP 15 mg 20 Softgels

NDC 63868-222-20

*Compare to the active ingredient in Robitussin® Lingering Cold Long-Acting CoughGels®

Carton Front

Carton Back

Bottle Label

COUGH RELIEF 
dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-222
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
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)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colorred (clear) Scoreno score
Shapecapsule (oval) Size13mm
FlavorImprint Code PC6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-222-201 in 1 CARTON07/13/2017
120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/13/2017
Labeler - Chain Drug Marketing Association Inc. (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(63868-222) , analysis(63868-222)

Revised: 12/2019
Document Id: 52e5aec2-ebdb-4096-bb67-b96772571fd1
Set id: 50844352-5ef3-4d01-a7ee-b60a332cd66d
Version: 2
Effective Time: 20191230
 
Chain Drug Marketing Association Inc.