NON-DROWSY NASAL DECONGESTANT PE- phenylephrine hcl tablet, film coated

Non-Drowsy Nasal Decongestant PE by

Drug Labeling and Warnings

Non-Drowsy Nasal Decongestant PE by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Phenylephrine HCl 10mg

INACTIVE INGREDIENT

croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide.

DOSAGE & ADMINISTRATION

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

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

  Ask a doctor

INDICATIONS & USAGE

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 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
• diabetes
• thyroid disease
• trouble urinating due to an enlarged prostate gland

* 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.

* OVERDOSE WARNING: Taking more than directed can cause serious health problems. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

*Keep out of reach of children.

* OVERDOSE WARNING: Taking more than directed can cause serious health problems. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

PURPOSE

Nasal Decongestant

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NON-DROWSY NASAL DECONGESTANT PE 
phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-100
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	S71
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-100-24	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/22/2018

Labeler - Strive Pharmaceuticals Inc. (080028013)