MUCUS RELIEF DM- dextromethorphan hbr/guaifenesin tablet 
KROGER 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.

----------

280R - KROGER MUCUS RELIEF DM

Each immediate-release tablet contains

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

Expectorant – Cough Suppressant

Helps loosen phlegm (mucus)

Helps thin bronchial secretions to make coughs more productive

Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

Directions: Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age do not use.

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.

Keep Out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center

30ct

MUCUS RELIEF DM 
dextromethorphan hbr/guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-280
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize10mm
FlavorImprint Code TCL280
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-280-0330 in 1 BOTTLE; Type 0: Not a Combination Product06/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/03/2019
Labeler - KROGER COMPANY (006999528)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(41226-280)

Revised: 5/2019
Document Id: 89697bdd-6c45-47bf-e053-2a95a90aa0ca
Set id: 813baf42-edb0-33a9-e053-2a91aa0a8599
Version: 2
Effective Time: 20190521
 
KROGER COMPANY