CONGESTAID II  - phenylephrine hydrochloride tablet 
Zee Medical Inc

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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Active Ingredient/Tablet Phenylephrine HCL 5 mg

Purpose-Nasal Decongestant

Temporarily relieves Nasal and sinus congestion due to: the common cold, hay fever, upper respiratory allergies

Adults: Take 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours

Children under 12 years, ask a doctor


•    Warnings:
•    Do not use:
•    more than the recommended dose
•    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 MAOI drug. If you do not know if your prescription 
drug contains an MAOI, consult a doctor or pharmacist before 
taking this product
Stop use and ask a doctor if:
•    symptoms do not improve
•    new symptoms occur
•    redness or swelling is present
•    nervousness, dizziness or sleeplessness occur
•    symptoms do not improve within 7 days or are accompanied by 
fever
Ask a doctor before use if you have:
•    heart disease
•    high blood pressure
•    thyroid disease
•    diabetes
•    difficulty in urination due to enlargement of the prostate gland

If pregnant or breast-feeding baby, 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.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

Inactive Ingredients: Crosscarmellose Sodium,  DC Red 27, Dicalcium Phosphate, Hypromellose, Magnesium Stearate,
Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Silicon Dioxide, Starch, Stearic Acid

MMCongestAid II, 250 Box 1


CONGESTAID II 
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-334
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
SILICON DIOXIDE 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
D&C RED NO. 27 
Product Characteristics
Colorwhite (snow white) Score no score
ShapeROUND (ZEE;CAII) Size6mm
FlavorImprint Code ZEE;CAII
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:35418-334-6850 CARTON ( PACKET) in 1 CARTONcontains a CARTON (35418-334-67)
1NDC:35418-334-67125 PACKET ( PACKET) in 1 CARTONThis package is contained within the CARTON (35418-334-68) and contains a PACKET (35418-334-02)
1NDC:35418-334-022 TABLET ( TABLET) in 1 PACKETThis package is contained within a CARTON (35418-334-67) and a CARTON (35418-334-68)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34106/12/2012

Labeler - Zee Medical Inc (009645623)
Registrant - Zee Medical Inc (009645623)
Establishment
NameAddressID/FEIOperations
Ultratab Laboratories, Inc.151051757manufacture
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack

Revised: 06/2012 Zee Medical Inc