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

Decongestant

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69168-272-93	1 in 1 CARTON	12/23/2014
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:69168-272-17	300 in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2021
3	NDC:69168-272-82	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	12/23/2014

Labeler - Allegiant Health (079501930)

Drug Facts