drug facts

drug facts
SPL v3
SPL
SPL Set ID 17eee39b-5a7a-ba20-e063-6294a90ac392
Route
oral
Published
Effective Date 2025-04-29
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 2024-08-16

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

Questions?


call 1-855-274-4122



PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105



your plus guarantee.

1-800-432-6111 or harristeeter.com



Made in India



*This product is not manufactured or distributed by RB HEALTH US LLC, distributor of Mucinex® DM.

Purposes

Cough suppressant

Expectorant

Active Ingredients

(in each extended-release tablet)



Dextromethorphan Hydrobromide USP 30 mg

Guaifenesin USP 600 mg

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 600 Mg/30 Mg (20 Tablet Blister Carton Label)

Harris Teeter



Compare to the

active ingredients

of Mucinex® DM*



Mucus

Relief DM

DEXTROMETHORPHAN HBr

AND GUAIFENESIN

EXTENDED-RELEASE

TABLETS 30 mg/
600 mg

Dextromethorphan HBr 30 mg - Cough Suppressant

Guaifenesin
600 mg - Expectorant

12 Hour

Controls Cough

Thins & Loosens Mucus

RELIEVES COUGH & CHEST CONGESTION

Actual Size

20 Extended-release 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)

Questions?


call 1-855-274-4122



PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105



your plus guarantee.

1-800-432-6111 or harristeeter.com



Made in India



*This product is not manufactured or distributed by RB HEALTH US LLC, distributor of Mucinex® DM.

Purposes

Cough suppressant

Expectorant

Active Ingredients (Active ingredients)

(in each extended-release tablet)



Dextromethorphan Hydrobromide USP 30 mg

Guaifenesin USP 600 mg

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 600 Mg/30 Mg (20 Tablet Blister Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (20 Tablet Blister Carton Label))

Harris Teeter



Compare to the

active ingredients

of Mucinex® DM*



Mucus

Relief DM

DEXTROMETHORPHAN HBr

AND GUAIFENESIN

EXTENDED-RELEASE

TABLETS 30 mg/
600 mg

Dextromethorphan HBr 30 mg - Cough Suppressant

Guaifenesin
600 mg - Expectorant

12 Hour

Controls Cough

Thins & Loosens Mucus

RELIEVES COUGH & CHEST CONGESTION

Actual Size

20 Extended-release Tablets




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)