MUCUS RELIEF DM- guaifenesin, dextromethorphan hbr tablet 
P & L Development, LLC

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 ingredients (in each tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

Cough Suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product,

do not use more than directed. 

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with 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

  • do not exceed 6 doses in 24 hours
  • take with a full glass of water 
  • adults and children 12 years of age and older
    • take 1 tablet every 4 hours
  • children under 12 years of age: do not use 

Other information

  • each tablet contains: sodium 20 mg low sodium
  • store at 20-25ºC (68-77ºF)

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions or comments?

Call 1-8777-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Mucus Relief DM

Guaifenesin 400 mg

Dextromethorphan HBr 20 mg

Expectorant • Cough Suppressant

Controls Cough

Thins and Loosens Mucus

Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

PARENTS: Learn about teen medicine abuse  www.StopMedicineAbuse.org

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

1 BOTTLE INSIDE

Package Label

Guaifenesin 400 mg, Dextromethorphan HBr 20 mg

Wellness Basics Mucus Relief DM Tablet

MUCUS RELIEF DM 
guaifenesin, dextromethorphan hbr tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-027
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize17mm
FlavorImprint Code TCL280;G2;G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-027-601 in 1 BOX07/31/201412/31/2019
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/31/201412/31/2019
Labeler - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: 078f2405-bc42-4741-a630-d38213981f3c
Set id: a14d75dc-e65b-4544-a2f9-50c2e80e0bbf
Version: 2
Effective Time: 20181221
 
P & L Development, LLC