CVS CHILDREN DECONGESTANT NOSE DROPS - phenylephrine hydrochloride solution 
TAI GUK PHARM. CO., LTD.

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.

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Drug Facts

Active ingredient                                                         Purpose

Phenylephrine Hydrochloride USP 0.125%...................Nasal Decongestant

Uses

Warnings

Ask a doctor before use if the child has

When using this product temporary discomfort may occur such as:

Stop use and ask a doctor if

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (Nasal use only)

Other information

Inactive ingredients

Benzalkonium Chloride, Edetate Disodium, Glycerin, Polyethylene Glycol, Potassium Phosphate Monobasic, Purified Water, Sodium Phosphate Dibasic

image of carton labelEnter section text here

CVS CHILDREN DECONGESTANT NOSE DROPS 
phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-9930
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68169-9930-61 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/12/2010
Labeler - TAI GUK PHARM. CO., LTD. (631101656)

Revised: 7/2010
Document Id: 4a7f4a56-1609-4ae0-9a2f-ff15d47cec32
Set id: 84ef5ce2-76f8-4209-9c7b-25296cf109a4
Version: 2
Effective Time: 20100712
 
TAI GUK PHARM. CO., LTD.