Phenylephrine by Rebel Distributors Corp PHENYLEPHRINE tablet

Phenylephrine by

Drug Labeling and Warnings

Phenylephrine by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PHENYLEPHRINE 
phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-524(NDC:24385-603)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	RED	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	L7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-524-18	18 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/24/2010

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK