Llorens- Tusnel Ped Drops 605

Llorens- Tusnel Ped Drops 605
SPL v4
SPL
SPL Set ID dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7
Route
ORAL
Published
Effective Date 2019-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
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) 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.

Stop 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

  • 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) 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

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredients in each (1 mL)

Guaifenesin 25 mg

Phenylephrine HCl 1.25 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • 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.

Stop 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

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients in each (1 mL)

Guaifenesin 25 mg

Phenylephrine HCl 1.25 mg


Advanced Ingredient Data


Raw Label Data

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