NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet

Nasal Decongestant PE by

Drug Labeling and Warnings

Nasal Decongestant PE by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, ELYSIUM PHARMACEUTICALS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Phenylephrine HCl 10mg

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• temporarily relieves sinus congestion and pressure

Warnings

Do not use ifyou 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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

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

• each tablet contains:phosphorus 10 mg
• store between 20°-25°C (68°-77°F)
• protect from excessive moisture
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

Crosscarmellose Soidum, Colloidal Silicon Dioxide, Dicalcium Phosphate, FD&C Red 40, Magnesium Stearate, Microcrystalline Cellulose

Questions?

call toll free 1-844-912-4012

SPL UNCLASSIFIED SECTION

Distributed by:

BI-MART

Eugene, OR 97402

PRINCIPAL DISPLAY PANEL-36 Count

NDC: 37835-651-36

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

36 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.

PRINCIPAL DISPLAY PANEL-100 Count

NDC: 37835-651-01

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT PE 
phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-651
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DICALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	S08
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-651-36	36 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2025
2	NDC: 37835-651-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/01/2025

Labeler - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		915664486	manufacture(37835-651)