Tussi Pres Pediatric

Tussi Pres Pediatric
SPL v6
SPL
SPL Set ID b01a45df-3cea-4729-80c1-7f35b7f707f0
Route
ORAL
Published
Effective Date 2025-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (75 mg) Phenylephrine (2.5 mg) Dextromethorphan (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-03-24 Until 2022-10-31

Description

Drug Facts

Purpose

Antitussive (Anti-Cough) Expectorant Nasal Decongestant


Medication Information

Purpose

Antitussive (Anti-Cough)

Expectorant

Nasal Decongestant

Description

Drug Facts

Uses:

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. 

• Temporarily relieves these symptoms occurring with a cold: nasal congestion and cough due to minor throat and bronchial irritation.

Section 42229-5

Drug Facts

Section 50565-1

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

Packaging

Warnings:

Do not use: • in a child under 2 years of age. • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if your child has:

• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus), or cough that lasts or is chronic such as occurs with asthma, chronic bronchitis or emphysema.

Do not use more than the recommended dose.

Stop use and ask a doctor if : • your child gets 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 persistent headache. These could be signs of a serious condition.

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

Directions:

Do not take more than 6 doses in any 24-hour period.

 Adults & Children 12 years of age and older  Take 4 teaspoons (20 mL) every 4 hours, as needed.
 Children 6 to under 12 years of age  Take 2 teaspoons (10 mL) every 4 hours, as needed.
 Children 2 to under 6  Take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed.
 Children under 2 years  Do not use.

Active Ingredients

Dextromethorphan HBr 5 mg

Guaifenesin 75  mg

Phenylephrine HCl 2.5 mg

Other Information:

• Tamper Evident. Do not use if packet is torn, cut or opened.

• Store at controlled room temperature 15° to 30°C (59° to 86°F).

• Avoid excessive heat or humidity.

Inactive Ingredients:

Citric acid, Flavor, Glycerin, Methylparaben, Propylene glycol, Propylparaben, Purified water, Sodium citrate and Sucralose


Structured Label Content

Uses:

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. 

• Temporarily relieves these symptoms occurring with a cold: nasal congestion and cough due to minor throat and bronchial irritation.

Section 42229-5 (42229-5)

Drug Facts

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.

Purpose

Antitussive (Anti-Cough)

Expectorant

Nasal Decongestant

Packaging

Warnings:

Do not use: • in a child under 2 years of age. • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if your child has:

• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus), or cough that lasts or is chronic such as occurs with asthma, chronic bronchitis or emphysema.

Do not use more than the recommended dose.

Stop use and ask a doctor if : • your child gets 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 persistent headache. These could be signs of a serious condition.

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

Directions:

Do not take more than 6 doses in any 24-hour period.

 Adults & Children 12 years of age and older  Take 4 teaspoons (20 mL) every 4 hours, as needed.
 Children 6 to under 12 years of age  Take 2 teaspoons (10 mL) every 4 hours, as needed.
 Children 2 to under 6  Take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed.
 Children under 2 years  Do not use.

Active Ingredients

Dextromethorphan HBr 5 mg

Guaifenesin 75  mg

Phenylephrine HCl 2.5 mg

Other Information:

• Tamper Evident. Do not use if packet is torn, cut or opened.

• Store at controlled room temperature 15° to 30°C (59° to 86°F).

• Avoid excessive heat or humidity.

Inactive Ingredients:

Citric acid, Flavor, Glycerin, Methylparaben, Propylene glycol, Propylparaben, Purified water, Sodium citrate and Sucralose


Advanced Ingredient Data


Raw Label Data

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