PHENYLEPHRINE HCL- phenylephrine hydrochloride tablet
A&Z Pharmaceutical, Inc.

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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Maximum Strength Non-Drowsy Decongestant PE

ACTIVE INGREDIENT (IN EACH TABLET)

Phenylephrine 10 mg

PURPOSE

Nasal Decongestant

USES

temporarily relieves ■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies and 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 ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland

When using this product

■ do not use more than directed

Stop use and ask a doctor if

■ you get nervous, dizzy, or sleepless ■ symptoms do not improve within 7 days or are accompanied by 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 immediately.

Directions

■ take every 4 to 6 hours ■ do not take more than 6 doses in 24 hours ■ adults and children 12 years of age and older: 1 tablet ■ children under 12 years of age: Consult a doctor

Other information

■ store at room temperature in a dry place ■ do not use if blister package is torn

Inactive ingredients

croscarmellose sodium, FD&C Red #40, FD&C Yellow #6, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

DISPLAY PANEL

PHENYLEPHRINE HCL
phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62211-272
Route of Administration	ORAL	DEA Schedule

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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (TYPE E) (UNII: 66O7AQV0RT)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE (UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	272
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62211-272-93	24 in 1 BOTTLE; 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	11/03/2009	05/05/2015

Labeler - A&Z Pharmaceutical, Inc. (926820705)

Registrant - A&Z Pharmaceutical, Inc. (926820705)

Name	Address	ID/FEI	Business Operations
Establishment
A&Z Pharmaceutical, Inc.		926820705	manufacture(62211-272)

Revised: 5/2015

Document Id: 82d6e365-5a92-4395-809f-80ccb37c7b5c

Set id: ebe17416-5754-4269-beb7-964afd2dcdfe

Version: 2

Effective Time: 20150505

A&Z Pharmaceutical, Inc.