FDA Label for Nasopen PE
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 15 ML (TBSP))
- PURPOSE
- USES
- WARNINGS
- DO NOT USE THIS PRODUCT
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS? COMMENTS?
- PRINCIPAL DISPLAY PANEL
Nasopen PE Product Label
The following document was submitted to the FDA by the labeler of this product Gm Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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:
- 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)
* Please review the disclaimer below.