FAST ACTING COUGH RELIEF DM - dextromethorphan hydrobromide and guaifenesin solution 
Winco Foods, 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.

----------

Fast Acting Cough Relief DM

Drug Facts

Active ingredients (in each 20 mL (4 tsp) dose)

Dextromethorphan HBr USP 20 mg
Guaifenesin USP 400 mg

Purposes

Cough suppressant
Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Warnings

Do not use

  • for children under 12 years of age
  • 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. Avoid foods or beverages that contain caffeine

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with 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 (1-800-222-1222) right away.

Directions

  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter; tsp = teaspoon
  • Adults and children 12 years and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
  • Children under 12 years of age: do not use unless directed by a doctor

Other information

  • each 20 mL contains: sodium 12 mg
  • tamper evident: do not use if printed seal under cap is torn or missing
  • store at 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red #40, flavors, glycerin, noncrystallizing sorbitol solution, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

Questions?

Call 800-824-1706 Monday - Friday 9am - 4pm MST

Distributed by
:
WINCO FOODS, LLC,
BOISE, ID 83704

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 6 FL OZ (180 mL Bottle)

*Compare to the active ingredients in
Mucinex® FAST-MAX™ DMMAX


WinCo®
Foods


Fast Acting
Cough Relief DM
Maximum Strength
 

DEXTROMETHORPHAN HBr 20 mg/
COUGH SUPPRESSANT
GUAIFENESIN 400 mg/EXPECTORANT

Controls Cough & Relieves Chest Congestion
•••••
Thins & Loosens Mucus
•••••
For Ages 12 & Over
•••••
4 Hour Dosing

6 FL OZ (180 mL)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 6 FL OZ (180 mL Bottle)

FAST ACTING COUGH RELIEF DM 
dextromethorphan hydrobromide and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-332
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
CHERRY (UNII: BUC5I9595W)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRY, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-332-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/201806/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/20/201806/01/2021
Labeler - Winco Foods, LLC. (056098817)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(67091-332)

Revised: 11/2020
 
Winco Foods, LLC.