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

Purpose

Cough Suppressant Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Medication Information

Active Ingredient

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
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
Other Information
  • store between 20-25ºC (68-77ºF)
Inactive Ingredients

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

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

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

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
Questions Or Comments?

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

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.

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

Active Ingredient (Active ingredient (in each tablet))

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
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
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

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

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
Questions Or Comments? (Questions or comments?)

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

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.

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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