ASSURED MAXIMUM STRENGTH NASAL DECONGESTANT- phenylephrine hcl tablet

Assured Maximum Strength Nasal Decongestant by

Drug Labeling and Warnings

Assured Maximum Strength Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC, Spirit Pharmaceuticals LLC , Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

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 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

When using this product do not exceed recommended dose

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur
■ symptoms do not improve within 7 days or occur with a fever

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

Keep out of reach of children. In case of overdose, get medical help or
contact a Poison Control Center right away. (1-800-222-1222)

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

Directions

• adults and children 12 years and over: ■ take 1 tablet every 4 hours ; ■ do not take more than 6 tablets in ; 24 hours
• children under 12 years: ask a doctor

Other information

store between 20° to 25°C (68° to 77°F)

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

QUESTIONS

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

ASSURED 

COMPARE TO ACTIVE INGREDIENT IN
SUDAFED® PE CONGESTION®†

MAXIMUM STRENGTH

Nasal Decongestant

· Phenylephrine HCl 10 mg - Nasal Decongestant

Relieves Nasal & Sinus Congestion,
Reduces Sinus Pressure, Non-Drowsy

Actual Size

PSEUDOEPHEDRINE FREE

24tablets

†This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Sudafed PE® Congestion

INGREDIENTS AND APPEARANCE

ASSURED MAXIMUM STRENGTH NASAL DECONGESTANT 
phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-1180
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	8mm
Flavor		Imprint Code	272
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-1180-2	1 in 1 CARTON	02/26/2019
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	02/26/2019

Labeler - Spirit Pharmaceuticals LLC (179621011)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	manufacture(68210-1180)