Llorens-triponel 508

Llorens-triponel 508
SPL v3
SPL
SPL Set ID cc774d33-96ce-4992-ad30-3cb03b0d119d
Route
ORAL
Published
Effective Date 2019-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Phenylephrine (5 mg) Triprolidine (1.25 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

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

Description

Active Ingredients (in each 5 mL) Dextromethorphan HBr 15 mg Phenylephrine HCl 5 mg Triprolidine HCl 1.25 mg


Medication Information

Warnings and Precautions

Warnings

Do not use if you are taking a 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 you r prescirption drug contains an MAOI, ask a doctor or pharmacist before using 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. 

When using this product

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness dizziness, or sleeplessness occurs
  • cough lasts for more than 7 days, comes back, or occurs with a beer, rash, or headache that lasts. These could be signs of a serious condition.
Indications and Usage

Uses

  • helps to control the reflex that causes coughing
  • temporarily relieves nasal congestion due to common cold, hay fever, or other upper respiratory allergies (allergic, rhinitis)
  • temporarily relieves these symptomes due to hay fever or ther upper respiratory allergies
  • runny nose
  • itchy, watery eyes
  • sneexing
  • itching of the nose or throat
Dosage and Administration

Direcations: Do 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
 Children 6 to under 12 years of age  Take 1 teaspoonful (5 mL) every 6 hours
 Children under 6  Ask a docotor

Description

Active Ingredients (in each 5 mL) Dextromethorphan HBr 15 mg Phenylephrine HCl 5 mg Triprolidine HCl 1.25 mg

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 flavor, citric acid, glycerin, methylparaben, 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

Nasal Decongestant

Antihistamine

Section 55106-9

Active Ingredients (in each 5 mL)

Dextromethorphan HBr 15 mg

Phenylephrine HCl 5 mg

Triprolidine HCl 1.25 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps to control the reflex that causes coughing
  • temporarily relieves nasal congestion due to common cold, hay fever, or other upper respiratory allergies (allergic, rhinitis)
  • temporarily relieves these symptomes due to hay fever or ther upper respiratory allergies
  • runny nose
  • itchy, watery eyes
  • sneexing
  • itching of the nose or throat
Dosage and Administration (34068-7)

Direcations: Do 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
 Children 6 to under 12 years of age  Take 1 teaspoonful (5 mL) every 6 hours
 Children under 6  Ask a docotor

Warnings and Precautions (34071-1)

Warnings

Do not use if you are taking a 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 you r prescirption drug contains an MAOI, ask a doctor or pharmacist before using 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. 

When using this product

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness dizziness, or sleeplessness occurs
  • cough lasts for more than 7 days, comes back, or occurs with a beer, 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 flavor, citric acid, glycerin, methylparaben, 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

Nasal Decongestant

Antihistamine

Section 55106-9 (55106-9)

Active Ingredients (in each 5 mL)

Dextromethorphan HBr 15 mg

Phenylephrine HCl 5 mg

Triprolidine HCl 1.25 mg


Advanced Ingredient Data


Raw Label Data

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