DEXTROMETHORPHAN HYDROBROMIDE- dextromethorphan hydrobromide capsule, liquid filled 
Spirit Pharmaceuticals LLC

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DEXTROMETHORPHAN HBr 15mg SOFT GELATIN CAPSULES

Drug Facts

Active ingredient (in each liquid-filled capsule)

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
  • trouble urinating due to an enlarged prostate gland

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.

Directions

  • do not take more than 8 capsules in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
adults and children 12 years and overtake 2 capsules every 6 to 8 hours, as needed
children under 12 yearsdo not use

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive ingredients

FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

Distributed By: Greenbrier International, Inc. Chesapeake, VA 23320

PRINCIPAL DISPLAY PANEL - 15 Softgels Bottle Label

COMPARE TO ACTIVE INGREDIENT OF
ROBITUSSIN ® LONG ACTING COUGH GELS ©*

ASSURED™

ADULT LONG LASTING
Cough Relief

Dextromethorphan HBr, 15 mg

  • Cough suppressant
  • Relieves cough for up to 8 hours
  • Non-drowsy / Non-narcotic

15 softgels

AGES 12+

image description
DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0005
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint Code 404
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-0005-01 in 1 CARTON11/22/2017
115 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/22/201712/07/2023
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0bf31114-1aa5-2361-e063-6394a90a4750
Set id: 7f24f63c-812c-4050-8743-9295093f62bd
Version: 7
Effective Time: 20231207
 
Spirit Pharmaceuticals LLC