Label: NASOPEN PE- phenylephrine hydrochloride, thonzylamine hydrochloride liquid
- NDC Code(s): 58809-729-04
- Packager: GM Pharmaceuticals, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 27, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 15 mL (TBSP))
- Purpose
- Uses
-
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
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
-
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.
- Do not exceed recommended dosage.
- Other information
- Inactive ingredients
- Questions? Comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NASOPEN PE
phenylephrine hydrochloride, thonzylamine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-729 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 15 mL THONZYLAMINE HYDROCHLORIDE (UNII: 6K9YKD48Y4) (THONZYLAMINE - UNII:R79646H5Z8) THONZYLAMINE HYDROCHLORIDE 50 mg in 15 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor COTTON CANDY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58809-729-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2012 11/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/03/2012 11/30/2024 Labeler - GM Pharmaceuticals, INC (793000860)