NASAL DECONGESTANT MAXIMUM STRENGTH- phenylephrine hcl tablet
P & L Development, LLC

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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Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

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

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

high blood pressure
heart disease
thyroid disease
diabetes
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.

In case of overdose, get medical help or contact a Poison Control Center 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: do not use this product for children under 12 years of age

Other information

store at 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminium lake, FD&C yellow #6 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, stearic acid, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Sudafed PE®†

maximum strength

nasal decongestant pe

non-drowsy

phenylephrine HCl 10 mg

sinus pressure
congestion

tablets

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

ReadyInCase Nasal Decongestant PE Tablets

NASAL DECONGESTANT MAXIMUM STRENGTH
phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59726-670
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	T234
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59726-670-18	18 in 1 CARTON	02/28/2014	12/31/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:59726-670-36	36 in 1 CARTON	02/28/2014	12/31/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	02/28/2014	12/31/2020

Labeler - P & L Development, LLC (800014821)

Revised: 9/2019

Document Id: 67d01f94-bb9a-46f3-94b9-cdd76b721bda

Set id: 2751c345-9331-4a7f-985e-77bcd69dc82b

Version: 2

Effective Time: 20190904

P & L Development, LLC