Llorens-tusnel Dmpeddrops 603

Llorens-tusnel Dmpeddrops 603
SPL v9
SPL
SPL Set ID d915eab8-013e-4ce3-b358-0d531e5ca1ba
Route
ORAL
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (25 mg) Pseudoephedrine (7.5 mg) Dextromethorphan (2.5 mg)
Inactive Ingredients
Fd&c Blue No. 1 Citric Acid Monohydrate Glycerin Sodium Benzoate Saccharin Sodium Propylene Glycol Water D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1993-01-01

Description

Active Ingredients in each 1 mL (dropperful)                    Purpose Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant Guaifenesin........................25mg................................................Expectorant Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant


Medication Information

Warnings and Precautions



Warnings



Do not use in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, ask a doctor or pharmacist before giving this product.

Indications and Usage


Other information

  • store at controlled room temperature 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature]

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

Dosage and Administration


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

Age

Weight Dose
Children 2 to under

6 years of age
24 -47 lbs

 Take 2 mL (two dropperfuls)

 every 4 to 6 hours

Children under 2 years of age

Under 24 lbs

 ask a doctor



Description

Active Ingredients in each 1 mL (dropperful)                    Purpose Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant Guaifenesin........................25mg................................................Expectorant Pseudoephedrine HCl..........7.5mg..............................................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 50570-1



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 (mucus)

  • a persistent or chronic cough such as occurs with asthma



When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs

  • symptoms do not get better within 7 days or accompanied by fever

  • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.
Section 51727-6



Inactive ingredients citric acid, D and C Red Number 33,FD and C Blue #1, flavor, glycerin, propylene glycol, sodium benzoate, sodium saccharin, water.

Section 51945-4

Section 53413-1

Questions or Comments? 1-866-595-5598

Section 55105-1

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.



Section 55106-9

Active Ingredients in each 1 mL (dropperful)                    Purpose

Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant

Guaifenesin........................25mg................................................Expectorant

Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant






Structured Label Content

Indications and Usage (34067-9)


Other information

  • store at controlled room temperature 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature]

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

Dosage and Administration (34068-7)


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

Age

Weight Dose
Children 2 to under

6 years of age
24 -47 lbs

 Take 2 mL (two dropperfuls)

 every 4 to 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 who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, ask a doctor or pharmacist before giving this product.

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 50570-1 (50570-1)



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 (mucus)

  • a persistent or chronic cough such as occurs with asthma



When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs

  • symptoms do not get better within 7 days or accompanied by fever

  • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.
Section 51727-6 (51727-6)



Inactive ingredients citric acid, D and C Red Number 33,FD and C Blue #1, flavor, glycerin, propylene glycol, sodium benzoate, sodium saccharin, water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments? 1-866-595-5598

Section 55105-1 (55105-1)

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.



Section 55106-9 (55106-9)

Active Ingredients in each 1 mL (dropperful)                    Purpose

Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant

Guaifenesin........................25mg................................................Expectorant

Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant






Advanced Ingredient Data


Raw Label Data

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