Llorens- Tusnel Cv 520

Llorens- Tusnel Cv 520
SPL v5
SPL
SPL Set ID 403935ac-5111-4f8b-80ae-1bd47ae774c7
Route
ORAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Codeine Anhydrous (10 mg) Guaifenesin (100 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Fd&c Red No. 40 Citric Acid Monohydrate Sodium Benzoate Saccharin Sodium Sorbitol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1995-01-01

Description

Active Ingredients(in each 5 ml tsp.)                                  Purpose Codeine Phosphate ................................................. 10 mg .......... Cough Suppressant Guaifenesin .......................................................... 100 mg .................. Expectorant Pseudoephedrine HCl ............................................. 30 mg .......... Nasal Decongestant


Medication Information

Warnings and Precautions

Warnings

Do not use if 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.

When using this product

do nol exceed recommended dosage

• may cause or aggravate constipation

Indications and Usage


Other information



  • store at controlled room temperature 20°- 25°C (68°- 77°F)
  • Each teaspoonful (5 ml) contains: sodium 2mg

  • Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.

Dosage and Administration

Directions: Follow dosage chartDosage may be repeated every 6 hours. Not to exceed 4 doses in 24-hours. Giving a higher dose

than recommended by a doctor could result in serious side effects for your child. A special measuring

device should be used to give an accurate dose of this product to children under 6 years of age.

Age Weight Dose
children 12 years of age and over 95 lbs and up  Take 2 teaspoonfuls (10 mL)

 every 6 hours
Children 6 to under 12 years of age 45 lbs to under 95 lbs  Take 1 teaspoonful (5mL)

 every 6 hours
Children under 6 years of age under 45 lbs  ask a doctor

Description

Active Ingredients(in each 5 ml tsp.)                                  Purpose Codeine Phosphate ................................................. 10 mg .......... Cough Suppressant Guaifenesin .......................................................... 100 mg .................. Expectorant Pseudoephedrine HCl ............................................. 30 mg .......... Nasal Decongestant

Section 50565-1

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

Section 50570-1



Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus) 
  • a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. chronic pulmonary disease or shortness of breath, or who are taking other drugs

Stop use and ask a doctor if



  • you get nervous, dizzy or sleepless. symptoms do not get better within 7 days or are accompanied by fever. cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could be signs of a serious condition.

Section 51727-6

Inactive ingredientsaspartame, citric acid, glycerine, methylparaben,

natural and artificial flavors, potassium citrate, potassium sorbate,

propylene glycol, propylparaben, purified water.

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

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves: nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis, cough due to minor bronchial irritation as may occur with the common cold
  • temporarily restores freer breathing through the nose
  • calms the cough control center and relieves coughing
Section 55106-9

Active Ingredients(in each 5 ml tsp.)                                  Purpose

Codeine Phosphate ................................................. 10 mg .......... Cough Suppressant

Guaifenesin .......................................................... 100 mg .................. Expectorant

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


Structured Label Content

Indications and Usage (34067-9)


Other information



  • store at controlled room temperature 20°- 25°C (68°- 77°F)
  • Each teaspoonful (5 ml) contains: sodium 2mg

  • Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.

Dosage and Administration (34068-7)

Directions: Follow dosage chartDosage may be repeated every 6 hours. Not to exceed 4 doses in 24-hours. Giving a higher dose

than recommended by a doctor could result in serious side effects for your child. A special measuring

device should be used to give an accurate dose of this product to children under 6 years of age.

Age Weight Dose
children 12 years of age and over 95 lbs and up  Take 2 teaspoonfuls (10 mL)

 every 6 hours
Children 6 to under 12 years of age 45 lbs to under 95 lbs  Take 1 teaspoonful (5mL)

 every 6 hours
Children under 6 years of age under 45 lbs  ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use if 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.

When using this product

do nol exceed recommended dosage

• may cause or aggravate constipation

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)



Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus) 
  • a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. chronic pulmonary disease or shortness of breath, or who are taking other drugs

Stop use and ask a doctor if



  • you get nervous, dizzy or sleepless. symptoms do not get better within 7 days or are accompanied by fever. cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could be signs of a serious condition.

Section 51727-6 (51727-6)

Inactive ingredientsaspartame, citric acid, glycerine, methylparaben,

natural and artificial flavors, potassium citrate, potassium sorbate,

propylene glycol, propylparaben, purified water.

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)

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves: nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis, cough due to minor bronchial irritation as may occur with the common cold
  • temporarily restores freer breathing through the nose
  • calms the cough control center and relieves coughing
Section 55106-9 (55106-9)

Active Ingredients(in each 5 ml tsp.)                                  Purpose

Codeine Phosphate ................................................. 10 mg .......... Cough Suppressant

Guaifenesin .......................................................... 100 mg .................. Expectorant

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


Advanced Ingredient Data


Raw Label Data

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