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Generic: phenylephrine hydrochloride, thonzylamine hydrochloride is used for the treatment of Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


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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


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:
  • nasal congestion
  • reduces swelling of the nasal passages
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

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

  • Do not exceed recommended dosage.
  • Use enclosed dosage cup or tablespoon (TBSP).
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

  • Each 15 mL (TBSP) contains: Sodium 6 mg.
  • Store at 59-86°F (15-30°C).

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)





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