Soothe Comfort I Cough Syrup

Manufacturer
RFX Pharmaceutical Co., Ltd.
Effective date
2021-04-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:04

Label at a glance#

ProductSoothe Comfort I Cough Syrup Original
Active ingredientDEXTROMETHORPHAN
Label structure13 sections

Dosage and administration

■ do not take more than 4 doses in any 24-hour period ■ one dose is two tablespoons (TBSP) ■ this adult product is not intended for use in children under 12 years of age Age Dose adults and children 12 years 30 mL (2TBSP) and over every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Label contents#

Full prescribing information#

Active ingredient (in each 30 ml/2TBSP)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan 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.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

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 two tablespoons (TBSP)

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

Age Dose

adults and children 12 years 30 mL (2TBSP)

and over every 6 hours

children 4 to under 12 years ask a doctor

children under 4 years do not use

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

astragalus root extract, coltsfoot flower bud extract, epimedium leaf extract, honey, schisandra fruit extract, water, white mulberry root bark extract

Questions or comments?

OTC - QUESTIONS SECTION

■ 1-800-860-0888

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

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
76206-004-012022-07-29C16284748780-1e4f33bdf-b1b3-d8a0-e053-dadaa90a6e4eRFXLMSootheComfortICghSyrp

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76206-004-01Soothe Comfort I Cough SyrupOriginal1 in 1 BOXLIQUID11
76206-004-05Soothe Comfort I Cough SyrupOriginal155 mL in 1 BOTTLE, GLASSLIQUID1551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76206-004SOOTHE COMFORT I COUGH SYRUP ORIGINAL (DEXTROMETHORPHAN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1Legacy NDC, 2 package rows20210429_c10b207e-27da-ea5e-e053-2995a90a8db4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76206-00476206-004-05, 76206-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
c10b2094-f34a-5930-e053-2995a90a7420c10b207e-27da-ea5e-e053-2995a90a8db42021-04-28WarningsExact identifier
spl id: c10b2094-f34a-5930-e053-2995a90a7420
spl set id: c10b207e-27da-ea5e-e053-2995a90a8db4

Reported adverse events (FAERS/openFDA)#

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