COUGH RELIEF- dextromethorphan hbr capsule, liquid filled 
Spirit Pharmaceuticals LLC

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Cough Relief

Drug Facts

Active ingredient (in each softgel)

Dextromethorphan HBr, USP 15mg

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 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 orcontact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12 years and overtake 2 capsules every 6 to 8 hours, as needed
children under 12 yearsdo not use

Other information

Inactive ingredients

FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Cough Relief

Dextromethorphan HBr 15mg

60 softgels

CoughRelief pouch 1

CoughRelief Pouch 2

COUGH RELIEF 
dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4242
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBITOL (UNII: 506T60A25R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint Code 404;904
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4242-61 in 1 POUCH01/03/2023
160 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/03/2023
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0bdd4770-5c0f-f6bb-e063-6394a90a617e
Set id: b05ca9da-e3df-4a44-8c5a-602e0c91cd46
Version: 3
Effective Time: 20231206
 
Spirit Pharmaceuticals LLC