COUGH OUT  - guaifenesin liquid 
Efficient Laboratories Inc.

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Drug Facts

Active Ingredient: (In each teaspoonful 5 mls)         Purpose

Guiafenesin 100 mg (USP)................................................Expectorant

Uses

• Help loosen phlegm (mucus) and thin bronchial secretions to red the bronchial passageways of bothersome mucus and makes coughs more productive.

Warnings

A persistent cough may be a sign of a serious condition.

Do not use

• this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 

Stop use and ask a doctor

• if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact the Poison Control Center right away.

If pregnant or breast-feeding,ask a health professional before use.

Directions:

Shake well immediately before use.

Do not exceed 6 doses in any 24 hour period.

Adults and Children 12 years and over - 10 ml (2 tsps) every 4 hours
Children 6 to under 12 years of age - 5 ml (1 tsp) every 4 hours
Children under 6 years of age - Do not use

Other Information:Each 5 ml contains: sodium 6 mg, and potassium 2 mg. Phenylketonurics: Contains Phenylalanine 6.75 mg per 5 mls (teaspoonful).

Tamper Evident Feature:Do not use if the cap seal is torn, broken or mission. Store between 15 degrees Celsius - 30 degrees Celcius (59 degrees Fahrenheit - 86 degrees Fahrenheit). Does not contain alcohol or narcotic. Product color and flavor may vary due to natural honey.

Inactive Ingredients:Aloe Vera, Aspartame, Honey, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com

COUGH OUT  guaifenesin   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 58593-255 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF   HONEY   MENTHOL   POTASSIUM SORBATE   PROPYLENE GLYCOL   PROPYLPARABEN   METHYLPARABEN   WATER   SODIUM CHLORIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58593-255-04 118 mL In 1 BOTTLE None 2 58593-255-06 178 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/1997

Labeler - Efficient Laboratories Inc. (969044932)

Registrant - Efficient Laboratories Inc. (969044932)

Revised: 04/2011Efficient Laboratories Inc.