Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 49829083-5c0a-4620-bfb3-7103642368db
Route
ORAL
Published
Effective Date 2024-06-10
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 2020-09-01

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 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
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
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
KROGER Maximum Strength Mucus Relief DM
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

Questions Or Comments?

Call 1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredients of MUCINEX® FAST-MAX® DM MAX

for ages 12+

maximum Strength

FAST

Mucus Relief

DM Max

multi-Symptom

Dextromethorphan HBr 20 mg

Cough Suppressant

Guaifenesin 400 mg

Expectorant

Relieves

Chest Congestion

Controls Cough

Thin & Loosens Mucus

4 Hour Dosing

*Mucinex® Fast-Max® DM Max is a registered trademark of Reckitt Benckiser, Slough, UK. Reckitt Benckiser is not affiliated with The Kroger Co. or this product

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

DISTRIBUTED BY: THE KROGER CO.

CINCINNATI, OHIO 45202

www.kroger.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 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 accompanied by 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
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
KROGER Maximum Strength Mucus Relief DM
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

Questions Or Comments? (Questions or comments?)

Call 1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredients of MUCINEX® FAST-MAX® DM MAX

for ages 12+

maximum Strength

FAST

Mucus Relief

DM Max

multi-Symptom

Dextromethorphan HBr 20 mg

Cough Suppressant

Guaifenesin 400 mg

Expectorant

Relieves

Chest Congestion

Controls Cough

Thin & Loosens Mucus

4 Hour Dosing

*Mucinex® Fast-Max® DM Max is a registered trademark of Reckitt Benckiser, Slough, UK. Reckitt Benckiser is not affiliated with The Kroger Co. or this product

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

DISTRIBUTED BY: THE KROGER CO.

CINCINNATI, OHIO 45202

www.kroger.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 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 accompanied by too much phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

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