COUGH MEDICINE

Manufacturer
LM WHOLESALE HERBS | RFX Pharmaceutical Co., Ltd.
Effective date
2020-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:25

Label at a glance#

ProductCOUGH MEDICINE soothing relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Dosage and administration

■ do not take more than 4 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 6-8 hours Children under 12 years do not use

Label contents#

Full prescribing information#

Active ingredient (in each 10 ml)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan Hydrobromide 30 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Use

INDICATIONS & USAGE SECTION

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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

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.

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 4 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

AgeDose

Adults and Children one bottle (10 ml)

12 years and over every 6-8 hours

Children under 12 years do not use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Apricot kernel oil, fritillaria delavayi bulb, honey, water

Other information

SPL UNCLASSIFIED SECTION

■ Store at 20C-25ºC (68F-77º F). Do not refrigerate

Questions or comments?

OTC - QUESTIONS SECTION

■ 1-800-860-0888

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN1
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD1
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY1
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75663-002-012022-01-28C16284748780-1d6a99b39-3ed7-a426-e053-dadaa90af4c2LM Cough Medicine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75663-002-01COUGH MEDICINEsoothing relief6 in 1 BOXLIQUID61
75663-002-10COUGH MEDICINEsoothing relief10 mL in 1 BOTTLE, GLASSLIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75663-002COUGH MEDICINE SOOTHING RELIEF (DEXTROMETHORPHAN) LIQUID [LM WHOLESALE HERBS]1Legacy NDC, 2 package rows20200531_a6d4f8b7-a61e-b322-e053-2995a90a3514.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75663-00275663-002-10, 75663-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
a6d4e323-52ef-49d5-e053-2995a90a68aba6d4f8b7-a61e-b322-e053-2995a90a35142020-05-29WarningsExact identifier
spl id: a6d4e323-52ef-49d5-e053-2995a90a68ab
spl set id: a6d4f8b7-a61e-b322-e053-2995a90a3514

Reported adverse events (FAERS/openFDA)#

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