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DEXTROMETHORPHAN Hydrobromide by Spirit Pharmaceuticals LLC

Medically reviewed on Nov 20, 2017

Dosage form: capsule, liquid filled
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg
Labeler: Spirit Pharmaceuticals LLC
NDC Code: 68210-0005

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.

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+

DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
POVIDONES 
WATER 
GELATIN 
GLYCERIN 
SORBITOL 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
TITANIUM DIOXIDE 
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint Code404
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0005-01 BOTTLE in 1 CARTON
115 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/22/2017
Labeler - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIOperations
MEDGEL PVT LTD677385498manufacture(68210-0005)

 
Spirit Pharmaceuticals LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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