FDA Label for Guaifenesin And Dextromethorphan Hbr

Active Ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 30 mg
Guaifenesin USP 600 mg

Purpose

Cough suppressant
Expectorant

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.

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)

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.

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

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)

Questions?

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

Package Label-Principal Display Panel - 600 Mg/30 Mg (14 Tablet Bottle)

NDC 58602-714-05
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
600 mg/30 mg
EXPECTORANT AND COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Bottle) - guaifedextro fig1

Package Label-Principal Display Panel - 600 Mg/30 Mg (14 Tablet Carton Label)

Compare to the active
ingredients of Mucinex® DM*
NDC 58602-714-05
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
600 mg/30 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Carton Label) - guaifedextro fig2

Package Label-Principal Display Panel - 600 Mg/30 Mg Blister Carton 20 (2 X 10) Unit-Dose Tablets

Compare to the active
ingredients of Mucinex® DM*
NDC 58602-714-67
Mucus Relief DM
Guaifenesin and
Dextromethorphan HBr
Extended-release Tablets
600 mg/30 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
20 (2 x 10) Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg Blister Carton 20 (2 x 10) Unit-dose Tablets - guaifedextro fig3