Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 88bc399a-2b71-45a7-bdfb-226ff1df0536
Route
ORAL
Published
Effective Date 2025-04-10
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 2020-05-16
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
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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
  • children under 12 years of age: do not use
Questions?

call 1-855-274-4122



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Other Information


  • 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 (2 X 7) Tablets Blister Carton Label

Healthy Living  



Compare to the active ingredients of

Maximum Strength Mucinex® DM*



MAXIMUM STRENGTH

Mucus Relief DM

Dextromethorphan HBr and Guaifenesin

Extended-release Tablets 60 mg/1200 mg

Dextromethorphan HBr    60 mg - Cough Suppressant

Guaifenesin 1200 mg - Expectorant

 

RELIEVES COUGH & CHEST CONGESTION



√     Controls Cough

√     Thins & Loosens Mucus



12

HOUR



63

ACTUAL SIZE  

14 (2 x 7)   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
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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
  • children under 12 years of age: do not use
Questions?

call 1-855-274-4122



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



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 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 (2 X 7) Tablets Blister Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg 14 (2 x 7) Tablets Blister Carton Label)

Healthy Living  



Compare to the active ingredients of

Maximum Strength Mucinex® DM*



MAXIMUM STRENGTH

Mucus Relief DM

Dextromethorphan HBr and Guaifenesin

Extended-release Tablets 60 mg/1200 mg

Dextromethorphan HBr    60 mg - Cough Suppressant

Guaifenesin 1200 mg - Expectorant

 

RELIEVES COUGH & CHEST CONGESTION



√     Controls Cough

√     Thins & Loosens Mucus



12

HOUR



63

ACTUAL SIZE  

14 (2 x 7)   Extended-release Tablets  





Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:31.386492 · Updated: 2026-03-14T23:12:46.294226