Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 15e54152-dc82-6442-e063-6294a90a8541
Route
ORAL
Published
Effective Date 2025-07-16
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg) Dextromethorphan (30 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone K90 Povidone K25 Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: X;62 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-27
Description

(in each extended-release tablet) Dextromethorphan Hydrobromide USP 30 mg Guaifenesin USP 600 mg

Purpose

Cough suppressant Expectorant

Medication Information

Purpose

Cough suppressant Expectorant

Description

(in each extended-release tablet) Dextromethorphan Hydrobromide USP 30 mg Guaifenesin USP 600 mg

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
Purposes

Cough suppressant

Expectorant

Warnings

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.
Directions


  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 1 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
  • children under 12 years of age: do not use
Other Information
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 30 mg

Guaifenesin USP 600 mg

Inactive Ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions Or Comments?


Call 1-800-632-6900

 

PROUDLY DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 45202



MADE IN INDIA 

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 illness
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 accompanied by too much phlegm (mucus)
Package Label Principal Display Panel 30 Mg/600 Mg (40 Tablets Blister Carton Label)

NDC 30142-276-40



Kroger®

health



COMPARE TO THE ACTIVE INGREDIENTS

IN MUCINEX® DM EXTENDED-RELEASE

BI-LAYER TABLETS*



Mucus Relief DM

 

Dextromethorphan HBr and

Guaifenesin Extended-release

Tablets 30 mg/6 00 mg

Dextromethorphan HBr 30 mg - Cough Suppressant

Guaifenesin 600 mg - Expectorant

R ELIEVES COUGH & CHEST CONGESTION

12 HOUR

CONTROLS                                        ACTUAL SIZE

COUGH



THINS &                                             40 EXTENDED-RELEASE

LOOSENS MUCUS                             TABLETS



Structured Label Content

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
Purposes

Cough suppressant

Expectorant

Warnings

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.
Directions


  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 1 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
  • children under 12 years of age: do not use
Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients (Active ingredients)

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 30 mg

Guaifenesin USP 600 mg

Inactive Ingredients (Inactive ingredients)


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions Or Comments? (Questions or comments?)


Call 1-800-632-6900

 

PROUDLY DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 45202



MADE IN INDIA 

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 illness
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 accompanied by too much phlegm (mucus)
Package Label Principal Display Panel 30 Mg/600 Mg (40 Tablets Blister Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 30 mg/600 mg (40 Tablets Blister Carton Label))

NDC 30142-276-40



Kroger®

health



COMPARE TO THE ACTIVE INGREDIENTS

IN MUCINEX® DM EXTENDED-RELEASE

BI-LAYER TABLETS*



Mucus Relief DM

 

Dextromethorphan HBr and

Guaifenesin Extended-release

Tablets 30 mg/6 00 mg

Dextromethorphan HBr 30 mg - Cough Suppressant

Guaifenesin 600 mg - Expectorant

R ELIEVES COUGH & CHEST CONGESTION

12 HOUR

CONTROLS                                        ACTUAL SIZE

COUGH



THINS &                                             40 EXTENDED-RELEASE

LOOSENS MUCUS                             TABLETS



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:32.924759 · Updated: 2026-03-14T23:09:23.715399