FDA Label for Chest Congestion Relief

Active Ingredient

(in each intermediate release tablet)

Guaifenesin 400 mg

Dextromethorphan HBr 20 mg

Purpose

Expectorant

Cough Suppressant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
• helps loosen phelgm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Do not use

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 your prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• cough accompanied by too much of phelgm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• when using this product do not use more than directed

Stop use and ask 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 condition.

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 right away. (1-800-222-1222)

Directions

• take with full glass of water;

  1 tablet every 4 hours

• do not take more than 6 tablets in 24 hours
• children under 12 years: do not use

Other Information

• store at 25° C(77°F) ; excursion permitted between 15°-30° C (59°-86°F)
• see end flap for expiration date and lot number
• metal content per tablet:
• sodium 7mg, Magnesium 1mg

Inactive Ingredients

Colloidal Silicon Dioxide, Hypromellose, Microcrystalline cellulose, Magnesium stearate, Polyethylene Glycol, Stearic Acid powder, Sodium Starch Glycolate

Questions Or Comments

Call 1-855-314-1850

Package Label.Principal Display Panel

66014619-figure-01 - 66014619 figure 01

NDC 62011-0319-1