Cough Out

Dosage form: liquid
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: Efficient Laboratories Inc.
NDC Code: 58593-255

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-255
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
HONEY 
MENTHOL 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
METHYLPARABEN 
WATER 
SODIUM CHLORIDE 
ASPARTAME 
Packaging
#Item CodePackage Description
1NDC:58593-255-04118 mL in 1 BOTTLE
2NDC:58593-255-06178 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/1997
Labeler - Efficient Laboratories Inc. (969044932)
Registrant - Efficient Laboratories Inc. (969044932)

Revised: 04/2011
 
Efficient Laboratories Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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