Xpect Decongestant by Cintas Corporation Xpect Decongestant

Xpect Decongestant by

Drug Labeling and Warnings

Xpect Decongestant by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

XPECT DECONGESTANT- phenylephrine tablet 
Cintas Corporation

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.

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Xpect Decongestant

Phenylephrine HCl 5mg

Active ingredients (in each tablet):
Phenylephrine HCl 5mg……………Nasal Decongestant

Temporarily relieves nasal congestion due to:
Common cold, hay fever or other upper respiratory allergies
Sinus congestion and pressure helps decongest sinus openings and passages
Temporarily restores free breathing through the nose

Temporarily relieves nasal congestion due to:
Common cold, hay fever or other upper respiratory allergies
Sinus congestion and pressure helps decongest sinus openings and passages
Temporarily restores free breathing through the nose
3. Warning(s) (c)(5)
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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult 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 enlarged prostate gland
When using this product do not exceed recommended dose
Stop using and ask doctor if:
Nervousness, dizziness or sleeplessness occur
Symptoms do not improve within 7 days or are accompanied by fever
New symptoms occur
If pregnant or breast-feeding, ask 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.

Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.

Adults and children 12 years of age and older: Take 2 tablets every 4 hours not to exceed 8 tablets in 24 hours, unless directed by a doctor.
Children under 12 years of age: Ask a doctor.

Do not use if package is torn, cut, or opened
Store at room temperature 59-86F (15-30C)
Avoid excessive heat and humidity

crosscarmellose sodium, D&C Red #27, dicalcium phosphate, Hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, starch, stearic acid

XPECT DECONGESTANT 
phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-205
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
PHOSPHATE ION (UNII: NK08V8K8HR)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYDEXTROSE (UNII: VH2XOU12IE)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-205-02	80 in 1 BOX	02/27/2021
1	NDC: 42961-205-01	2 in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/27/2021	12/31/2022

Labeler - Cintas Corporation (056481716)

Registrant - Cintas Corporation (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra-Tab Laboratories, Inc.		151051757	manufacture(42961-205)

Revised: 12/2022

Document Id: 352a5d50-bae4-481a-8981-1b903a13e9c7

34390-5

Set id: 11077704-936c-4e1a-b9d9-8d4cc2ec1b94

Version: 4

Effective Time: 20221231