Goodsense Tussin Cf Multi-symptom Cold, Raspberry

Goodsense Tussin Cf Multi-symptom Cold, Raspberry
SPL v1
SPL
SPL Set ID 3f05cf84-d485-7688-e063-6394a90ae740
Route
ORAL
Published
Effective Date 2024-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Water Fd&c Red No. 40 Sorbitol Solution 70% Sucralose Glycerin Sodium Benzoate Anhydrous Citric Acid Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-05

Description

Active ingredients (in each 5 mL or 1 teaspoon) Purposes Dextromethorphan HBr, 10 mg........................................................ Cough Suppressant Guaifenesin, 100 mg................................................................................... Expectorant Phenylephrine HCI, 5 mg................................................................ Nasal Decongestant


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold:

• nasal congestion • cough due to minor throat and bronchial irritation

Dosage and Administration

Directions • do not take more than 6 doses in any 24 hour period • this adult

strength product is not intended for use in children under 12 years of age • measure

only with dosing cup provided • keep dosing cup with product • TSP= teaspoon

age dose
adults and children 12 years and over 2 teaspoons (10 mL) every 4 hours
children under 12 years do not use
Description

Active ingredients (in each 5 mL or 1 teaspoon) Purposes Dextromethorphan HBr, 10 mg........................................................ Cough Suppressant Guaifenesin, 100 mg................................................................................... Expectorant Phenylephrine HCI, 5 mg................................................................ Nasal Decongestant

Section 34088-5

Do not exceed recommended dosage.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if • you get nervous, dizzy or sleepless

• symptoms do not get better within 7 days or are accompanied by fever • cough lasts

more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other oral nasal

decongestant or stimulant.

Section 50569-3

Ask a doctor before use if you have • heart disease • high blood pressure

• thyroid disease • diabete s • trouble urinating due to an enlarged prostate gland

• cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic

such as occurs with smoking, asthma, chronic bronchitis or emphysema

Section 50570-1

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.

Section 51727-6

Inactive ingredients anhydrous citric acid, FD&C red #40, glycerin, propylene

glycol, purified water, raspberry flavor, sodium benzoate, sorbitol solution, sucralose

Section 51945-4

Section 53413-1

Questions or comments? 1-888-446-4753 Monday - Friday from

8 AM - 5 PM Eastern Standard Time.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active ingredients (in each 5 mL or 1 teaspoon) Purposes

Dextromethorphan HBr, 10 mg........................................................ Cough Suppressant

Guaifenesin, 100 mg................................................................................... Expectorant

Phenylephrine HCI, 5 mg................................................................ Nasal Decongestant

Section 60561-8

Other information

each teaspoon (5mL) contains: sodium 3 mg

• store at 15-30°C (59-86°F ). Do not refrigerate.


Structured Label Content

Indications and Usage (34067-9)

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold:

• nasal congestion • cough due to minor throat and bronchial irritation

Dosage and Administration (34068-7)

Directions • do not take more than 6 doses in any 24 hour period • this adult

strength product is not intended for use in children under 12 years of age • measure

only with dosing cup provided • keep dosing cup with product • TSP= teaspoon

age dose
adults and children 12 years and over 2 teaspoons (10 mL) every 4 hours
children under 12 years do not use
Warnings and Precautions (34071-1)

Warnings

Section 34088-5 (34088-5)

Do not exceed recommended dosage.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if • you get nervous, dizzy or sleepless

• symptoms do not get better within 7 days or are accompanied by fever • cough lasts

more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other oral nasal

decongestant or stimulant.

Section 50569-3 (50569-3)

Ask a doctor before use if you have • heart disease • high blood pressure

• thyroid disease • diabete s • trouble urinating due to an enlarged prostate gland

• cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic

such as occurs with smoking, asthma, chronic bronchitis or emphysema

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients anhydrous citric acid, FD&C red #40, glycerin, propylene

glycol, purified water, raspberry flavor, sodium benzoate, sorbitol solution, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-888-446-4753 Monday - Friday from

8 AM - 5 PM Eastern Standard Time.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL or 1 teaspoon) Purposes

Dextromethorphan HBr, 10 mg........................................................ Cough Suppressant

Guaifenesin, 100 mg................................................................................... Expectorant

Phenylephrine HCI, 5 mg................................................................ Nasal Decongestant

Section 60561-8 (60561-8)

Other information

each teaspoon (5mL) contains: sodium 3 mg

• store at 15-30°C (59-86°F ). Do not refrigerate.


Advanced Ingredient Data


Raw Label Data

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