DEXTROMETHORPHAN HYDROBROMIDE- dextromethorphan hydrobromide capsule, liquid filled 
ONE2ZEE LIMITED LIABILITY COMPANY

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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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.

Directions

Other information

Inactive ingredients

polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, gelatin, glycerin, sorbitol, water

PRINCIPAL DISPLAY PANEL

Bulk Label

DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-011
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint Code IS3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55629-011-0148 in 1 CARTON02/05/2021
1NDC:55629-011-02750 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/05/2021
Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Establishment
NameAddressID/FEIBusiness Operations
Medgel Private Limited677385498manufacture(55629-011)

Revised: 3/2023
Document Id: d67fcfe3-e54b-4450-9db2-756f4e492fbd
Set id: 0ffaa7d8-713f-4e4a-beca-2401de17de6f
Version: 3
Effective Time: 20230325
 
ONE2ZEE LIMITED LIABILITY COMPANY