Fast Acting Cough Relief DM

Manufacturer
Winco Foods, LLC. | Aurohealth LLC
Effective date
2020-11-26
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:03:48

Label at a glance#

ProductFast Acting Cough Relief DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

Indications and 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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

Dextromethorphan HBr USP 20 mg
Guaifenesin USP 400 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-33267091-332-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9aad7d5f-5ce6-4e55-baf9-775e1227054e7a10c274-3951-4d64-ae46-287404eef9db2020-11-26WarningsExact identifier
spl id: 9aad7d5f-5ce6-4e55-baf9-775e1227054e
spl set id: 7a10c274-3951-4d64-ae46-287404eef9db

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.