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
Purpose

Cough suppressant Expectorant

Description

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

Questions?

call 1-855-274-4122



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Purposes

Cough suppressant

Expectorant

Active Ingredients

( in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 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 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

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 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
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



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Purposes

Cough suppressant

Expectorant

Active Ingredients (Active ingredients)

( in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 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 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