Llorens- Tusnel 502

Llorens- Tusnel 502
SPL v8
SPL
SPL Set ID 805dc611-355a-4af5-bf19-464c3290c5c6
Route
ORAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Guaifenesin (200 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Sodium Citrate Sucralose Citric Acid Monohydrate Glycerin Methylparaben Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-01-01

Description

Active Ingredients(in each 5 ml tsp.)                                  Purpose Dextromethorphan HBr........15mg..................................................Cough Suppressant Guaifenesin........................200mg................................................Expectorant Pseudoephedrine HCl..........30mg..................................................Nasal Decongestant


Medication Information

Warnings and Precautions



Warnings

Do not useif you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement 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 you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if

  • 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:

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps control reflex that causes coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
Dosage and Administration



DirectionsDo not exceed more than 4 doses in any 24-hour period

or as directed by a doctor.

Age Dose
Adults and children

12 years of age and over
 Take 2 teaspoonfuls (10 mL)

 every 6 hours

Description

Active Ingredients(in each 5 ml tsp.)                                  Purpose Dextromethorphan HBr........15mg..................................................Cough Suppressant Guaifenesin........................200mg................................................Expectorant Pseudoephedrine HCl..........30mg..................................................Nasal Decongestant

Section 50565-1



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

Section 51727-6

Inactive ingredients: artificial grape flavor, citric acid, glycerin, methylparaben, polyethylene glycol, 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 health professional before use.

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredients(in each 5 ml tsp.)                                  Purpose

Dextromethorphan HBr........15mg..................................................Cough Suppressant

Guaifenesin........................200mg................................................Expectorant

Pseudoephedrine HCl..........30mg..................................................Nasal Decongestant






Structured Label Content

Indications and Usage (34067-9)

Uses:

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps control reflex that causes coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
Dosage and Administration (34068-7)



DirectionsDo not exceed more than 4 doses in any 24-hour period

or as directed by a doctor.

Age Dose
Adults and children

12 years of age and over
 Take 2 teaspoonfuls (10 mL)

 every 6 hours

Warnings and Precautions (34071-1)



Warnings

Do not useif you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement 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 you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if

  • 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 overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients: artificial grape flavor, citric acid, glycerin, methylparaben, polyethylene glycol, 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 health professional before use.

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients(in each 5 ml tsp.)                                  Purpose

Dextromethorphan HBr........15mg..................................................Cough Suppressant

Guaifenesin........................200mg................................................Expectorant

Pseudoephedrine HCl..........30mg..................................................Nasal Decongestant






Advanced Ingredient Data


Raw Label Data

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