DEXTROMETHORPHAN HYDROBROMIDE- dextromethorphan hydrobromide capsule, liquid filled 
J.P. BUSINESS ENTERPRISE

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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DEXTROMETHORPHAN HBr 15mg SOFT GELATIN CAPSULES

Drug Facts

Active ingredient (in each liquid-filled capsule)

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
  • 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 or contact a Poison Control Center right away.

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 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: J.P Business Enterprise
Lake Grove, NY 11755

PRINCIPAL DISPLAY PANEL - 15 Softgel Bottle Carton

VALUMEDS

Compare to the Active Ingredient of
ROBITUSSIN ® LONG-ACTING COUGHGELS ®*

ADULT LONG-LASTING
COUGH RELIEF

FOR AGES
12 & Over

DEXTROMETHORPHAN HBr, USP 15 mg

COUGH SUPPRESSANT

15 SOFTGELS**
**Liquid Filled Capsules

Principal Display Panel - 15 Softgel Bottle Carton
DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59105-006
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:59105-006-151 in 1 CARTON12/01/2014
115 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2014
Labeler - J.P. BUSINESS ENTERPRISE (078775890)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PVT LTD677385498manufacture(59105-006)

Revised: 12/2019
Document Id: 9aa9482e-0acb-6444-e053-2995a90ad027
Set id: 3ed4b972-ae80-49b0-a356-d6f117d482d2
Version: 2
Effective Time: 20191226
 
J.P. BUSINESS ENTERPRISE