ENDAL- triprolidine hcl, dextromethorphan hbr liquid 
Poly Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Endal

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:

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

AGEDOSE
Adults and children over 12 years of age2 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 age1 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 ageConsult 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 
triprolidine hcl, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-136
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-136-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2023
2NDC:50991-136-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/22/2023
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 1/2024
Document Id: 0ff1b3c8-8997-0b01-e063-6294a90aef10
Set id: fc5401e2-ed65-72e7-e053-6294a90a81f3
Version: 2
Effective Time: 20240127
 
Poly Pharmaceuticals, Inc.