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

• 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 toll-free, 1-855-874-0970 (English/Spanish) weekdays You may also report side effects to this phone number.

DISTRIBUTED BY:
Vespyr Brands®, Inc.
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 1200 Mg/60 Mg Blister Carton (21 (3 X 7)Tablets)

12                                    NDC 71179-011-21
HR

CONTAC_®
COUGH and EXPECTORANT
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets 1200 mg/60 mg
Expectorant and Cough Suppressant

Maximum Strength 

•Controls Cough  •Thins and Loosens Mucus

21 EXTENDED-RELEASE TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton (21 (3 x 7)Tablets) - guaifedextro fig1