COUGH BE GONE

Manufacturer
LM WHOLESALE HERBS
Effective date
2020-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:22

Label at a glance#

ProductCOUGH BE GONE
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 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

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

■ 1800-860-0888

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75663-001-012022-01-28C16284748780-1d6a99b39-3eef-a426-e053-dadaa90af4c2LM Cough be Gone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75663-001-01COUGH BE GONE6 in 1 BOXLIQUID61
75663-001-10COUGH BE GONE10 mL in 1 BOTTLE, GLASSLIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75663-001COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [LM WHOLESALE HERBS]1Legacy NDC, 2 package rows20200523_a6416800-29f1-1c78-e053-2995a90a03e9.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75663-00175663-001-10, 75663-001-01

Ingredients#

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

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

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a6414319-55ac-1d40-e053-2995a90afcd2a6416800-29f1-1c78-e053-2995a90a03e92020-05-22WarningsExact identifier
spl id: a6414319-55ac-1d40-e053-2995a90afcd2
spl set id: a6416800-29f1-1c78-e053-2995a90a03e9

Reported adverse events (FAERS/openFDA)#

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