Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a1921611-343c-4c2a-846d-c8de19dddab5
Route
ORAL
Published
Effective Date 2023-12-01
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 2021-02-24

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
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 or 2 tablets every 12 hours; not more than 4 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.



Manufactured by:

Aurobindo Pharma Limited

Unit-VII (SEZ)

Mahabubnagar (Dt)-509302

India



M.L.No.: 22/MN/AP/2009/F/R



Manufactured for:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

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 30 mg

Guaifenesin USP 600 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.
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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 10 (1 X 10) Tablets Carton Label

Healthy Living

NDC 58602-871-83

Compare to the active

ingredients of Mucinex® DM*



Mucus Relief DM

Guaifenesin and Dextromethorphan HBr

Extended-release Tablets 600 mg/30 mg



EXPECTORANT AND

COUGH SUPPRESSANT



Controls Cough

Thins and Loosens Mucus

12

HOUR



62

10 (1 x 10)
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 or 2 tablets every 12 hours; not more than 4 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.



Manufactured by:

Aurobindo Pharma Limited

Unit-VII (SEZ)

Mahabubnagar (Dt)-509302

India



M.L.No.: 22/MN/AP/2009/F/R



Manufactured for:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

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 30 mg

Guaifenesin USP 600 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.
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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 10 (1 X 10) Tablets Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg 10 (1 x 10) Tablets Carton Label)

Healthy Living

NDC 58602-871-83

Compare to the active

ingredients of Mucinex® DM*



Mucus Relief DM

Guaifenesin and Dextromethorphan HBr

Extended-release Tablets 600 mg/30 mg



EXPECTORANT AND

COUGH SUPPRESSANT



Controls Cough

Thins and Loosens Mucus

12

HOUR



62

10 (1 x 10)
Extended-release Tablets




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)