NASOPEN PE- phenylephrine hydrochloride, thonzylamine hydrochloride liquid 
GM Pharmaceuticals, INC

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Nasopen PE

Nasopen PE

NDC 58809-729-04

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child-resistant cap.

Distributed by: GM Pharmaceuticals, Inc.

Arlington, TX 76015

Drug Facts

Active ingredients (in each 15 mL (TBSP))

Phenylephrine HCl 10 mg

Thonzylamine HCl 50 mg

Purpose

Nasal Decongestant

Antihistamine

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to the enlargement of the prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

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 drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or accompanied by fever.
  • new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

Adults and children
12 years of age
and over:
15 mL (1 TBSP) every 4 hours,
not to exceed 90 mL (6 TBSP) in a
24 hour period.
Children 6 to under
12 years of age:
7.5 mL (1/2 TBSP) every 4 hours,
not to exceed 45 mL (3 TBSP) in a
24 hour period.
Children under
6 years of age:
Consult a doctor.

Other information

Inactive ingredients

citric acid anhydrous, cotton candy flavor, FD&C Red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose.

Questions? Comments?

Call 1-888-535-0305   9 a.m. - 5 p.m. CST.

R100716

PRINCIPAL DISPLAY PANEL

NDC 58809-729-04
NasOpenPE
Cotton Candy Flavor
4 fl.oz. (118 mL)

PRINCIPAL DISPLAY PANEL
NDC 58809-729-04
NasOpenPE
Cotton Candy Flavor
4 fl.oz. (118 mL)

PRINCIPAL DISPLAY PANEL
NDC 58809-729-04
NasOpenPE
Cotton Candy Flavor
4 fl.oz. (118 mL)

NASOPEN  PE
phenylephrine hydrochloride, thonzylamine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-729
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 15 mL
THONZYLAMINE HYDROCHLORIDE (UNII: 6K9YKD48Y4) (THONZYLAMINE - UNII:R79646H5Z8) THONZYLAMINE HYDROCHLORIDE50 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-729-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/03/201211/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/03/201211/30/2024
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 11/2023
Document Id: 0b281455-f2ce-fe79-e063-6394a90aadd6
Set id: 5e133352-255f-41cc-aacc-0508d634368d
Version: 8
Effective Time: 20231127
 
GM Pharmaceuticals, INC