drug facts

drug facts
SPL v2
SPL
SPL Set ID 3b5c5617-8499-7fc8-e063-6394a90aa86c
Route
oral
Published
Effective Date 2025-08-02
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 2017-03-17

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

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


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

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 (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)