Active Ingredient
Triprolidine HCl, Dextromethorphan HBr
Endal Liquid
FDA Label NDC 50991-136
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Endal (NDC 50991-136). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use this product, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistimine, Antitussive
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.
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.
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.
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.
- new symptoms occur
These could be signs of a serious
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.
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. |
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)
Package Label
Label (Endal)
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