Green-tussin®

Green-tussin®
SPL v1
SPL
SPL Set ID 05cf8616-c33a-4c0f-8b3d-280aaa2fbf7f
Route
ORAL
Published
Effective Date 2024-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Aloe Citric Acid Monohydrate Caramel Corn Syrup Eucalyptus Oil Ginger Honey Menthol, Unspecified Form Methylparaben Potassium Sorbate Propylene Glycol Propylparaben Water Sodium Benzoate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-14

Description

Dextromethorphan HBr 10 mg Guaifenesin 100 mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr 10 mg Guaifenesin 100 mg

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.

Section 42229-5

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

Section 50565-1

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

Keep out of reach of children.

Warnings

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.

Packaging

Directions

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

Drug Facts

Questions?

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

Other Information

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

Inactive Ingredients:

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.

Active Ingredients (in Each 15 Ml)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg


Structured Label Content

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.

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Keep out of reach of children.

Purpose

Cough Suppressant

Expectorant

Warnings

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.

Packaging

Directions

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

Drug Facts

Questions?

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

Other Information (Other information)

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

Inactive Ingredients: (Inactive ingredients:)

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.

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg


Advanced Ingredient Data


Raw Label Data

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