Endal

Endal
SPL v4
SPL
SPL Set ID fc5401e2-ed65-72e7-e053-6294a90a81f3
Route
ORAL
Published
Effective Date 2023-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triprolidine (1.25 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Sorbitol Solution Citric Acid Acetate Glycerin Sodium Citrate Water Sodium Benzoate Propylene Glycol Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-22

Description

Triprolidine HCl, Dextromethorphan HBr

Purpose

Antihistimine, Antitussive


Medication Information

Purpose

Antihistimine, Antitussive

Description

Triprolidine HCl, Dextromethorphan HBr

Uses

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
Warnings

Do not exceed recommended dosage.

Directions
AGE DOSE
Adults and children over 12 years of age 2 teaspoonfuls (10 mL) every 4 to 6 hours,

over 12 years not to exceed 8 teaspoonfuls in

of age: 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours,

12 years of age: not to exceed 4 teaspoonfuls in

24 hours, or as directed by a doctor.
Children under 6 years of age Consult a doctor.

Package Label

Active Ingredient

Triprolidine HCl, Dextromethorphan HBr

Other Information

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients

Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon - Fri (8 a.m. to 5 p.m. CST)

Do Not Use This Product

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

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • may cause or aggravate constipation
  • alcohol, sedatives, and tranquilizers may increase drowsiness effect
Stop Use and Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.

These could be signs of a serious

  • new symptoms occur
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of the Reach of Children

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

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
Ask A Doctor Or Pharmacist Before Use

if you are taking sedatives or tranquilizers.


Structured Label Content

Uses

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
Purpose

Antihistimine, Antitussive

Warnings

Do not exceed recommended dosage.

Directions
AGE DOSE
Adults and children over 12 years of age 2 teaspoonfuls (10 mL) every 4 to 6 hours,

over 12 years not to exceed 8 teaspoonfuls in

of age: 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours,

12 years of age: not to exceed 4 teaspoonfuls in

24 hours, or as directed by a doctor.
Children under 6 years of age Consult a doctor.

Package Label

Active Ingredient

Triprolidine HCl, Dextromethorphan HBr

Other Information

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients

Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon - Fri (8 a.m. to 5 p.m. CST)

Do Not Use This Product (Do not use this product)

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 (When using this product)

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • may cause or aggravate constipation
  • alcohol, sedatives, and tranquilizers may increase drowsiness effect
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.

These could be signs of a serious

  • new symptoms occur
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of the Reach of Children (Keep out of the reach of children)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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