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

Purpose

Cough suppressant Expectorant

Description

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


Medication Information

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.
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
Purpose

Cough suppressant Expectorant

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)
Inactive Ingredients


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

Description

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

Purposes

Cough suppressant

Expectorant

Active Ingredients

(in each extended-release tablet)



Dextromethorphan Hydrobromide USP 30 mg

Guaifenesin USP 600 mg

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

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.
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
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)
Inactive Ingredients (Inactive ingredients)


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

Purposes

Cough suppressant

Expectorant

Active Ingredients (Active ingredients)

(in each extended-release tablet)



Dextromethorphan Hydrobromide USP 30 mg

Guaifenesin USP 600 mg

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)