PHENYLEPHRINE- phenylephrine tablet 
Rebel Distributors Corp

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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Phenylephrine Drug Facts

Active ingredient

Phenylephrine hydrochloride 10 mg

Purpose

Nasal decongestant

Keep Out of Reach of Children

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

Uses

° temporarily relieves sinus congestion and pressure

° temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Warnings

Do not use if you are now taking a prescription monoamine exidase 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 ° diabetes ° trouble urinating due to an enlarge prostate gland ° thyroid disease

When using this product, do not use more than directed.

 

Stop use and ask a doctor if:

° you get nervous, dizzy or sleepless

° symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Directions

° take every 4 hours

° do not take more than 6 doses in 24 hours

° adults and children 12 years of age and over: 1 tablet

° children under 12 years of age: ask a doctor

Other information

Store at room temperature (59°-86°F)

Inactive ingredients

carnauba wax. dibasic calcium phosphate, FD&C red no. 40, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Package/Label Principal Display Panel

Phenylephrine 10mg

PHENYLEPHRINE 
phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-524(NDC:24385-603)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-524-1818 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/24/2010
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 2/2011
Document Id: c40df8f6-8374-4f9b-bfce-94d582470d48
Set id: c40df8f6-8374-4f9b-bfce-94d582470d48
Version: 1
Effective Time: 20110221
 
Rebel Distributors Corp