NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY- phenylephrine 10 mg tablet

Nasal Decongestant PE by

Drug Labeling and Warnings

Nasal Decongestant PE by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenylephrine HCl 10 mg

Purpose

Nasal Decongestant

Uses

temporarily relieves:

• nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
• nasal congestion associated with sinusitis 
• sinus congestion and pressure

Warnings

Do not use

Do not use if you are now taking a prescription mono-amine oxidase 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
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

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

Keep Out of Reach of Children

In case of accidentaloverdose, contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Adults and children 12 years of age and older: 
• 1 tablet every 4 to 6 hours. 
• Do not take more than 6 tablets in 24 hours
• Children under 12 years of age: ask a doctor

Inactive Ingredients

croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

If pregnant or breast-feeding,

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

Principal Display Panel

Phenylephrine HCl 10mg

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT PE  MAXIMUM STRENGTH NON-DROWSY
phenylephrine 10 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-272
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-272-93	1 in 1 CARTON	12/23/2014
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/23/2014

Labeler - Allegiant Health (079501930)