Llorens-tusnel Dm Ped 604

Llorens-tusnel Dm Ped 604
SPL v5
SPL
SPL Set ID 63541753-de8d-42fe-a9b3-a5eac3fcdca4
Route
ORAL
Published
Effective Date 2019-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (75 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Methylparaben Propylene Glycol Propylparaben Water Trisodium Citrate Dihydrate Sucralose

Identifiers & Packaging

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

In each 5 mL Dextromethorphan HBr - 5 mg Guaifenesin - 75 mg Phenylephrine HCl - 2.5 mg

Medication Information

Warnings and Precautions

Warnings

Do not use if your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

  • 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

Ask a doctor before use if your child is

  • taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if your child gets

  • 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

  • temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold
Dosage and Administration

Directions: Do not exceed 6 doses in 24 hour

 Age  Dose
Children 6 to under 12 years of age  Take 2 teaspoonful (10 mL) every 4 hours
Children 2 to under 6 years of age   Take 1 teaspoonful (5 mL) every 4 hours
Children under 2 years of age  Ask a doctor

Description

In each 5 mL Dextromethorphan HBr - 5 mg Guaifenesin - 75 mg Phenylephrine HCl - 2.5 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, 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 use

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

In each 5 mL

Dextromethorphan HBr - 5 mg

Guaifenesin - 75 mg

Phenylephrine HCl - 2.5 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold
Dosage and Administration (34068-7)

Directions: Do not exceed 6 doses in 24 hour

 Age  Dose
Children 6 to under 12 years of age  Take 2 teaspoonful (10 mL) every 4 hours
Children 2 to under 6 years of age   Take 1 teaspoonful (5 mL) every 4 hours
Children under 2 years of age  Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use if your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

  • 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

Ask a doctor before use if your child is

  • taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if your child gets

  • 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, 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 use

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

In each 5 mL

Dextromethorphan HBr - 5 mg

Guaifenesin - 75 mg

Phenylephrine HCl - 2.5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:00.549341 · Updated: 2026-03-14T23:12:08.624404