COUGH BE GONE- dextromethorphan hydrobromide guaifenesin liquid 
RFX Pharmaceutical Co., Ltd.

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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Drug Facts

Active ingredient (in 10 ml)

Dextromethorphan Hydrobromide 20 mg

Guaifenesin USP 200 mg

Purpose

Cough suppressant

Expectorant

Use

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ■ Helps loosen phlegm (mucus) and thin bronchial secretions 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 if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

■cough that occurs with too much phlegm (mucus)

■cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before

Keep out of reach of children

Directions

■ do not take more than 6 doses in any 24-hour period

■ one dose is one bottle

■ this adult product is not intended for use in children under 12 years of age

Age Dose

Adults and Children one bottle (10 ml)

12 years and over every 4 hours

Children under 12 years do not use

Inactive ingredients

Almond oil, Citrus peel, Ginger, Honey, Loquat leaf extract, Licorice, Menthol, Purified water

Other Information

■ Store at 20-25ºC (68-77ºF). Do not refrigerate

Questions or comments ?

■ 1-800-860-0888

Package Label

package label

COUGH BE GONE 
dextromethorphan hydrobromide guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76206-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALMOND OIL (UNII: 66YXD4DKO9)  
GINGER (UNII: C5529G5JPQ)  
HONEY (UNII: Y9H1V576FH)  
ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)  
LICORICE (UNII: 61ZBX54883)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorbrown (light brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76206-001-016 in 1 BOX01/30/2014
1NDC:76206-001-1010 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/30/2014
Labeler - RFX Pharmaceutical Co., Ltd. (530620871)
Establishment
NameAddressID/FEIBusiness Operations
RFX Pharmaceutical Co., Ltd.530620871manufacture(76206-001)

Revised: 5/2020
Document Id: a6cf8d75-ab8f-4044-e053-2a95a90a02e1
Set id: 89a5588f-a6a6-40dd-b96f-79bd3ea9e31f
Version: 4
Effective Time: 20200529
 
RFX Pharmaceutical Co., Ltd.