Llorens-tusnel Dm Ped Dr 606

Llorens-tusnel Dm Ped Dr 606
SPL v4
SPL
SPL Set ID 64e36b02-b5be-4d20-8818-cb5b23596671
Route
ORAL
Published
Effective Date 2019-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (2.5 mg) Guaifenesin (25 mg) Phenylephrine (1.25 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Methylparaben Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-01

Description

Active Ingredients in each (1 mL) Dextromethorphan HBr 2.5 mg Guaifenesin 25 mg Phenylephrine HCl 1.25 mg


Medication Information

Warnings and Precautions

Warnings

Do not use in child whos 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 your doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that occurs with too much phlegm
  • a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

When using this product

  • do not exceed the recommended dosage.

Stope use and ask doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not get better within 7 days or accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Indications and Usage

Uses

  • Temporary relief of cough due to minor throat and bronchial irritation
  • Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
  • Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.
Dosage and Administration

Directions

Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

 Age  Weight  Dose
 Children 2 to under 6 years of age  24-47 lbs  Take 2 mL every 4-6 hours
 Children under 2 years of age  Under 24 lbs  Ask a doctor

Description

Active Ingredients in each (1 mL) Dextromethorphan HBr 2.5 mg Guaifenesin 25 mg Phenylephrine HCl 1.25 mg

Section 50565-1

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

Section 51727-6

Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Section 51945-4

Section 53413-1

Questions or Comments? 1-866-595-5598

Section 55105-1

Purpose

Cough suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredients in each (1 mL)

Dextromethorphan HBr 2.5 mg

Guaifenesin 25 mg

Phenylephrine HCl 1.25 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Temporary relief of cough due to minor throat and bronchial irritation
  • Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
  • Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.
Dosage and Administration (34068-7)

Directions

Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

 Age  Weight  Dose
 Children 2 to under 6 years of age  24-47 lbs  Take 2 mL every 4-6 hours
 Children under 2 years of age  Under 24 lbs  Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use in child whos 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 your doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that occurs with too much phlegm
  • a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

When using this product

  • do not exceed the recommended dosage.

Stope use and ask doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not get better within 7 days or accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments? 1-866-595-5598

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients in each (1 mL)

Dextromethorphan HBr 2.5 mg

Guaifenesin 25 mg

Phenylephrine HCl 1.25 mg


Advanced Ingredient Data


Raw Label Data

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