Llorens-tusneldm 517

Llorens-tusneldm 517
SPL v6
SPL
SPL Set ID fe457e6d-422d-496c-bcb9-33594f3c42ff
Route
ORAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Menthol Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-01

Description

In each 5 mL Dextromethorphan HBr - 20 mg Guaifenesin - 400 mg Phenylephrine HCl - 10 mg


Medication Information

Warnings and Precautions

Warnings

Do not use if you are taking a 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 using this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargment of prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if you get

  • nervousness, dizziness, or sleeplessness occur
  • cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition.
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 exceed 6 doses in 24 hour

 Age  Dose
 Adults and children over 12 years of age  Take 5 mL (one teaspoonful) every 4 hours
 Children under 12 years of age  Ask a doctor

Description

In each 5 mL Dextromethorphan HBr - 20 mg Guaifenesin - 400 mg Phenylephrine HCl - 10 mg

Section 50565-1

Keep out of reach of children.In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients:artificial and natural flavor, citric acid, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Section 51945-4

Section 53413-1

Questions or Comments?1-866-595-5598

Section 53414-9

If pregnant or breast-feeding, ask a doctor before using this product

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

In each 5 mL

Dextromethorphan HBr - 20 mg

Guaifenesin - 400 mg

Phenylephrine HCl - 10 mg


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 exceed 6 doses in 24 hour

 Age  Dose
 Adults and children over 12 years of age  Take 5 mL (one teaspoonful) every 4 hours
 Children under 12 years of age  Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use if you are taking a 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 using this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargment of prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if you get

  • nervousness, dizziness, or sleeplessness occur
  • cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition.
Section 50565-1 (50565-1)

Keep out of reach of children.In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients:artificial and natural flavor, citric acid, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?1-866-595-5598

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a doctor before using this product

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

In each 5 mL

Dextromethorphan HBr - 20 mg

Guaifenesin - 400 mg

Phenylephrine HCl - 10 mg


Advanced Ingredient Data


Raw Label Data

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