ENDAL- triprolidine hcl, dextromethorphan hbr liquid

Endal by

Drug Labeling and Warnings

Endal by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Triprolidine HCl, Dextromethorphan HBr

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.

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.

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

INGREDIENTS AND APPEARANCE

ENDAL 
triprolidine hcl, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-136
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	1.25 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL SOLUTION (UNII: 8KW3E207O2)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-136-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2023
2	NDC: 50991-136-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/22/2023

Labeler - Poly Pharmaceuticals, Inc. (198449894)