drug facts

drug facts
SPL v3
SPL
SPL Set ID 782fb103-cd9f-4e8c-8f3a-1fb131b9eda6
Route
oral
Published
Effective Date 2023-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (20 mg) guaifenesin (400 mg)
Inactive Ingredients
anhydrous citric acid edetate disodium fd&c red no. 40 glycerin propyl gallate propylene glycol water sodium benzoate trisodium citrate dihydrate sorbitol sucralose xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-05-29

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Medication Information

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to 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
Purpose

Cough suppressant

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period 
  • measure only with dosing cup provided. Do not use any other device 
  • keep dosing cup with product
  • mL = milliliter
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and older: 20 mL every 4 hours
  • children under 12 years of age: do not use
Other Information
  • each 20 mL contains: sodium 20 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients

citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Principal Display Panel

Compare to the active ingredients in Maximum Strength Mucinex® FAST-MAX® DM Max*

ADULT

DM MAXIMUM

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN - Expectorant

MAXIMUM STRENGTH

Multi-Symptom

  • Relieves chest congestion
  • Control cough
  • Thins & loosens mucus

Dosing lasts 4 hours

For Ages 12 & Over

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DM Max

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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.

Package Label
CVS HEALTH Adult DM Maximum Strength
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.

Active Ingredients (in Each 20 Ml)

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 that occurs with too much phlegm (mucus)

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to 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
Purpose

Cough suppressant

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period 
  • measure only with dosing cup provided. Do not use any other device 
  • keep dosing cup with product
  • mL = milliliter
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and older: 20 mL every 4 hours
  • children under 12 years of age: do not use
Other Information (Other information)
  • each 20 mL contains: sodium 20 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Principal Display Panel

Compare to the active ingredients in Maximum Strength Mucinex® FAST-MAX® DM Max*

ADULT

DM MAXIMUM

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN - Expectorant

MAXIMUM STRENGTH

Multi-Symptom

  • Relieves chest congestion
  • Control cough
  • Thins & loosens mucus

Dosing lasts 4 hours

For Ages 12 & Over

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DM Max

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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 product.

Package Label
CVS HEALTH Adult DM Maximum Strength
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.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

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 that occurs with too much phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

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