FDA Label for Guaifenesin And Dextromethorphan Hbr

Active Ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 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 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years of age: do not use

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)

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 - 1200 Mg/60 Mg 14 (2 X 7) Tablets Carton Label

HealthyLiving

NDC 58602-849-65
Compare to the active ingredients of
Maximum Strength Mucinex^® DM^*

MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets 1200 mg/60 mg

EXPECTORANT AND
COUGH SUPPRESSANT

Controls Cough
Thins and Loosens Mucus

12
HOUR

63
14 (2 x 7) Extended-release Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg 14 (2 x 7) Tablets Carton Label - guaifedextro fig1