COUGH OUT- guaifenesin liquid 
Efficient Laboratories Inc.

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.

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Cough Out

Active Ingredient: (In each teaspoonful 5 mls)         Purpose

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

Purpose Expectorant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

Warnings

Do not exceed recommended dosage

Ask a doctor before use if you have

Stop use and ask a doctor if

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

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

Each 5 mls contains: sodium 5 mg, and potassium 5 mg

Phenylketonurics: Contains Phenylalanine 2.5 mg per 5 ml (teaspoonful). 

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com


CoughOutLabel

COUGH OUT 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-255
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HONEY (UNII: Y9H1V576FH)  
MENTHOL (UNII: L7T10EIP3A)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
ASPARTAME (UNII: Z0H242BBR1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58593-255-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/199705/16/2023
2NDC:58593-255-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/1997
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)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58593-255)

Revised: 5/2023
Document Id: fbd30955-dbad-8dce-e053-6394a90ae78f
Set id: fe4c3921-8d30-4cd6-ba90-9211b362a38a
Version: 6
Effective Time: 20230516
 
Efficient Laboratories Inc.