COUGH BE GONE

Manufacturer: RFX Pharmaceutical Co., Ltd.
Effective date: 2020-05-29
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:15:15

Label at a glance#

ProductCOUGH BE GONE

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure12 sections

Dosage and administration

■ 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

Contacts and useful links#

PhoneLabel contact1-800-860-0888

Label contents#

Full prescribing information#

Active ingredient (in 10 ml)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan Hydrobromide 20 mg

Guaifenesin USP 200 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Use

INDICATIONS & USAGE SECTION

■ 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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

■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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

INACTIVE INGREDIENT SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

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

Questions or comments ?

OTC - QUESTIONS SECTION

■ 1-800-860-0888

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	4
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	4
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	4
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	4
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76206-001-01	2022-01-28	C162847	48780-1	9d75b9d0-d2f7-f424-e053-dadaa90a57ce	Drug Facts
76206-001-01	2020-03-03	C162847	48780-1	9d75b9d0-d2f7-f424-e053-dadaa90a57ce	Drug Facts
76206-001-01	2020-01-31	C162847	48780-1	9d75b9d0-d2f7-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76206-001-01	COUGH BE GONE	6 in 1 BOX	LIQUID	6		4
76206-001-10	COUGH BE GONE	10 mL in 1 BOTTLE, GLASS	LIQUID	10		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76206-001	COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]	4	Legacy NDC, 2 package rows	20200530_89a5588f-a6a6-40dd-b96f-79bd3ea9e31f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	1
ERIOBOTRYA JAPONICA LEAF	INACTIVE INGREDIENT	Z02066SV11	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	1
LICORICE	INACTIVE INGREDIENT	61ZBX54883	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

COUGH BE GONE
Dextromethorphan Hydrobromide Guaifenesin
ALMOND OIL
GINGER
HONEY
ERIOBOTRYA JAPONICA LEAF
LICORICE
MENTHOL, UNSPECIFIED FORM
WATER
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76206-001	76206-001-10, 76206-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALMOND OIL	66YXD4DKO9	IACT
GINGER	C5529G5JPQ	IACT
HONEY	Y9H1V576FH	IACT
ERIOBOTRYA JAPONICA LEAF	Z02066SV11	IACT
LICORICE	61ZBX54883	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
WATER	059QF0KO0R	IACT
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MENTHOL	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	MOUTHWASH / BUCCAL	0.15 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
GINGER	GINGER	C5529G5JPQ	SYRUP / ORAL	0.05 ml/5ml		Exact identifier — unii candidate 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	JELLY / NASAL	32.5 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
ALMOND OIL	ALMOND OIL	66YXD4DKO9	CREAM / TOPICAL	2 %w/w		Exact identifier — unii candidate
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
GINGER	GINGER	C5529G5JPQ	ELIXIR / ORAL	10 mg/5ml		Exact identifier — unii candidate 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	PASTE, DENTIFRICE / DENTAL	4.7 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a6cf8d75-ab8f-4044-e053-2a95a90a02e1			89a5588f-a6a6-40dd-b96f-79bd3ea9e31f	2020-05-29	Warnings	Exact identifier spl id: a6cf8d75-ab8f-4044-e053-2a95a90a02e1 spl set id: 89a5588f-a6a6-40dd-b96f-79bd3ea9e31f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.