NDC | 65923-005-54 |
Set ID | 7a79b1e0-e019-4ab7-9445-c0348293c3ba |
Category | HUMAN OTC DRUG LABEL |
Packager | UNITED EXCHANGE CORP |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
-
PURPOSE
Uses
- temporarily relieves nasal congestion, due to common cold, hay fever, or other upper respiratory allergies
- helps clear nasal passages; shrinks swollen membranes
- temporarily restores freer breathing through the nose
- helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS
phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-005 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 1.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-005-54 1 in 1 BOX 1 15 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/10/2012 Labeler - UNITED EXCHANGE CORP (840130579)