Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 8857ac96-5810-41eb-b275-a4eb04c721aa
Route
ORAL
Published
Effective Date 2025-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: TLC280 Shape: round Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-06-30 Until 2026-06-30

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes 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
Directions
  • do not exceed 6 tablets 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 while symptoms persist
  • children under 12 years of age: do not use
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 drug.

Package Label
GOOD SENSE Mucus Relief DM
Other Information
  • store between 20-25ºC (68-77ºF)
Inactive Ingredients

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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Immediate Acting

Mucus Relief DM

EXPECTORANT / COUGH SUPPRESSANT

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg TABLETS

  • Controls Cough
  • Thin & Loosens Mucus

Dye-Free

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Geiss, Destin & Dunn. Inc., A Perrigo Company

Peachtree City, GA 30269

www.PerrigoDirect.com

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.

Active Ingredient (in Each Tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accopanied by too much phlegm (mucus)

Structured Label Content

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes 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
Purpose

Cough Suppressant

Expectorant

Directions
  • do not exceed 6 tablets 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 while symptoms persist
  • children under 12 years of age: do not use
Do Not Use (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 drug.

Package Label
GOOD SENSE Mucus Relief DM
Other Information (Other information)
  • store between 20-25ºC (68-77ºF)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Immediate Acting

Mucus Relief DM

EXPECTORANT / COUGH SUPPRESSANT

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg TABLETS

  • Controls Cough
  • Thin & Loosens Mucus

Dye-Free

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Geiss, Destin & Dunn. Inc., A Perrigo Company

Peachtree City, GA 30269

www.PerrigoDirect.com

When Using This Product, (When using this product,)

do not use more than directed

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accopanied by too much phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

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