Label: CVS CHILDREN DECONGESTANT NOSE DROPS- phenylephrine hydrochloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 68169-9930-6 - Packager: TAI GUK PHARM. CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 12, 2010
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- ACTIVE INGREDIENT
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS CHILDREN DECONGESTANT NOSE DROPS
phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68169-9930 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 GLYCOL (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68169-9930-6 1 in 1 CARTON 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/12/2010 Labeler - TAI GUK PHARM. CO., LTD. (631101656)