FDA.reportPublic FDA data

Only For

Manufacturer
O4 Global Trading Usa, Llc
Effective date
2019-05-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:34

Label at a glance#

ProductOnly For COUGH
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

take with a full glass of water do not take more than 6 tablets in 24 hours .  adults and children 12 years of age & over 1 tablet every 4 hrs  children under 12 years of age  Do not use

Storage and handling

• Store at room temperature between 20-25°C (68-77°F). • Store in a dry place • Avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Dextromethorphan HBr 20mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Cough suppressant

Uses:

INDICATIONS & USAGE SECTION

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

• helps loosen phlegm (mucus) and thin bronchial secretions to 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.     

• if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.

Stop use and consult a doctor

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

Ask a doctor before use if you have

• persistent cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough accompanied by too much phlegm (mucus)

When using this product

• do not exceed recommended dosage.

• do not use for more than 7 days

May cause or aggravate constipation.

If pregnant or breast-feeding,

ask a healthcare professional before use.

Keep out of reach of children. Overdose Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • take with a full glass of water
  • do not take more than 6 tablets in 24 hours.
 adults and children 12 years of age & over1 tablet every 4 hrs
 children under 12 years of age Do not use

Other Information:

STORAGE AND HANDLING SECTION

• Store at room temperature between 20-25°C (68-77°F).
• Store in a dry place
• Avoid excessive heat.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl povidone, sodium starch glyconate, stearic acid, talc

Questions Or Comments ?

OTC - QUESTIONS SECTION

1-833-665-9444.

SPL UNCLASSIFIED SECTION

NDC: 73006-101-41

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

Tear along perforation push product through foil

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN2
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD2
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY2

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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73006-101-412022-01-28C16284748780-1d6a99b39-504d-a426-e053-dadaa90af4c2Only For - COUGH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73006-101-41Only ForCOUGH1 in 1 CARTONTABLET12
73006-101-41Only ForCOUGH4 in 1 BLISTER PACKTABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73006-101ONLY FOR COUGH (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [O4 GLOBAL TRADING USA, LLC]2Legacy NDC, 2 package rows20190530_72bb9fd7-c172-403e-84ad-5cdd9f7c6008.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73006-10173006-101-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM PALMITOSTEARATER4OXA9G5BVIACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT

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
d326094d-da65-4aa8-ba27-494f61b3ad3772bb9fd7-c172-403e-84ad-5cdd9f7c60082019-05-28WarningsExact identifier
spl id: d326094d-da65-4aa8-ba27-494f61b3ad37
spl set id: 72bb9fd7-c172-403e-84ad-5cdd9f7c6008

Reported adverse events (FAERS/openFDA)#

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