GENCARE-NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet

Gencare-Nasal Decongestant PE by

Drug Labeling and Warnings

Gencare-Nasal Decongestant PE by is a Otc medication manufactured, distributed, or labeled by Pioneer Life Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Phenylephrine HCl 10mg

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.

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 right away. (1-800 222-1222).

DIRECTIONS:

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

OTHER INFORMATION

• store between 20-25°C (68-77°F)
• do not use if seal under cap is broken or missing

INACTIVE INGREDIENTS

Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Polyvinyl Alcohol, Polyethylene Glycol, FD&C Red #40/Allura Red AC Aluminum Lake, Talc, Titanium Dioxide.

QUESTIONS OR COMMENTS?

Call 1-732-698-5070 Mon - Fri 9am - 5pm EST.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENCARE-NASAL DECONGESTANT PE 
phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72090-025
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DICALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	SO8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72090-025-01	300 in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/07/2024

Labeler - Pioneer Life Sciences, LLC (014092742)

Registrant - Pioneer Life Sciences, LLC (014092742)