Phenylephrine

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-524

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.

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 
phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-524(NDC:24385-603)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
FD&C RED NO. 40 
LECITHIN, SOYBEAN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POLYVINYL ALCOHOL 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeL7
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-524-1818 TABLET (TABLET) 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/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 02/2011
 
Rebel Distributors Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)