Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID bf4bcec8-7136-4ae7-a459-a30ee881b98d
Route
ORAL
Published
Effective Date 2024-03-29
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg) Dextromethorphan (60 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone K90 Povidone K25 Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: X;63 Shape: oval Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2017-08-07

Description

( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 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
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 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 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use
Questions?


call 1-855-274-4122  You may also report side effects to this phone number.



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



Distributed By

AmerisourceBergen

1300 Morris Drive

Chesterbrook, PA 19087



Questions or Concerns?

www.mygnp.com

Other Information


  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients

( in each extended-release tablet)



Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

Inactive Ingredients


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

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 1200 Mg/60 Mg (14 Tablet Carton Label)

Compare to Maximum

Strength Mucinex® DM

active ingredients*



GOOD

NEIGHBOR

PHARMACY®



NDC 46122-420-74

12 Hour

maximum strength

Mucus . DM

guaifenesin and dextromethorphan HBr

extended-release tablets

1200 mg/60 mg

Expectorant/Cough Suppressant

  • Controls Cough
  • Thins and Loosens Mucus


14 Extended-Release 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
Purpose

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 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 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use
Questions?


call 1-855-274-4122  You may also report side effects to this phone number.



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



Distributed By

AmerisourceBergen

1300 Morris Drive

Chesterbrook, PA 19087



Questions or Concerns?

www.mygnp.com

Other Information (Other information)


  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients (Active ingredients)

( in each extended-release tablet)



Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

Inactive Ingredients (Inactive ingredients)


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

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 1200 Mg/60 Mg (14 Tablet Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label))

Compare to Maximum

Strength Mucinex® DM

active ingredients*



GOOD

NEIGHBOR

PHARMACY®



NDC 46122-420-74

12 Hour

maximum strength

Mucus . DM

guaifenesin and dextromethorphan HBr

extended-release tablets

1200 mg/60 mg

Expectorant/Cough Suppressant

  • Controls Cough
  • Thins and Loosens Mucus


14 Extended-Release Tablets




Advanced Ingredient Data


Raw Label Data

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