FDA.reportPublic FDA data

GREEN TUSSIN DM PEDIATRIC

Manufacturer
Green Choice for Life
Effective date
2024-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:16

Label at a glance#

ProductGREEN TUSSIN DM PEDIATRIC
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

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

Dosage and administration

• Do not exceed 6 doses in 24 hours.  age dose   children 6 to under 12 years of age  15 mL (3 TSP) every 4 hours                                children 2 to under 6 years of age  7.5 mL (1 ½TSP) every 4 hours

Storage and handling

• store this product between 15 to 30°C (59° to 86°F)

Label contents#

Full prescribing information#

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg
Guaifenesin 100 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use:
• Ask a doctor before use for a persistent or chronic cough such as occurs with asthma, chronic bronchitis or if cough is accompanied by excessive phlegm (mucus).
• Stop use and ask a doctor if cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
• Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOl) (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 child's prescription drug contains an MAOl, ask a doctor or pharmacist before giving this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

• Do not exceed 6 doses in 24 hours.

 agedose 
 children 6 to under 12 years of age 15 mL (3 TSP) every 4 hours                              
 children 2 to under 6 years of age 7.5 mL (1 ½TSP) every 4 hours

Other information

STORAGE AND HANDLING SECTION

• store this product between 15 to 30°C (59° to 86°F)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe, Citric Acid, Caramel Color, Corn Syrup, Eucalyptus Oil, Ginger Root PE, Honey, Natural and Artificial Honey Flavor, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum.

Questions?

OTC - QUESTIONS SECTION

call 305-763-3228 M-F 9 am to 5 pm Eastern.

SPL UNCLASSIFIED SECTION

COUGH & CHEST CONGESTION

with Natural Ingredients

• Aloe
• Honey
• Ginger
• Eucalyptus

NON DROWSY • NO ALCOHOL • NO GLUTEN

TAMPER EVIDENT FEATURE: DO NOT USE THIS PRODUCT IF IMPRINTED CELLO-BAND OVER CAP IS TORN, BROKEN OR MISSING.

SHAKE WELL BEFORE USING

Distributed by:
Green Choice for Life
304 Indian Trace #445
Weston, FL 33326

www.greenchoiceforlife.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEDIATRICPEDIATRIC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298228dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral SolutionPSN1
1298228dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral SolutionSCD1
1298228dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral SolutionSY1
1298228dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55287-443-06GREEN TUSSIN DM PEDIATRIC1 in 1 CARTONLIQUID11
55287-443-06GREEN TUSSIN DM PEDIATRIC180 mL in 1 BOTTLELIQUID1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55287-443GREEN TUSSIN DM PEDIATRIC (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [GREEN CHOICE FOR LIFE]12 package rows20240328_05cf8616-c33a-4c0f-8b3d-280aaa2fbf7f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55287-44355287-443-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ALOEV5VD430YW9IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CARAMELT9D99G2B1RIACT
CORN SYRUP9G5L16BK6NIACT
EUCALYPTUS OIL2R04ONI662IACT
GINGERC5529G5JPQIACT
HONEYY9H1V576FHIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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
d803c34c-56c1-4742-bf7e-63eaf08d654805cf8616-c33a-4c0f-8b3d-280aaa2fbf7f2024-03-14WarningsExact identifier
spl id: d803c34c-56c1-4742-bf7e-63eaf08d6548
spl set id: 05cf8616-c33a-4c0f-8b3d-280aaa2fbf7f

Reported adverse events (FAERS/openFDA)#

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