MEDIQUE MEDI-PHENYL - phenylephrine hydrochloride tablet, film coated
DOVER SUDANYL PE - phenylephrine hydrochloride tablet, film coated
Unifirst First Aid Corporation

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 5mg

Purpose

Nasal decongestant

Uses

Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies.

Promotes nasal and/or sinus drainage; 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

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dosage
if nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor

Stop use and ask a doctor if

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 right away.

Directions

do not use more than directed

Adults and children: (12 years and older) Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age

Other information

read all product information before using.
contains FD&C yellow #6 (tartrazine)
store at room temperature 59º-86º F (15º-30º C).
tamper evident sealed packets.
do not use any opened or torn packets

Inactive ingredients

colloidal silica*, croscarmellose sodium, D&C Red #27*, dicalcium phosphate*, FD&C red #40*, FD&C yellow #6*, hypromellose*, lactose*, magnesium stearate,

microcrystalline cellulose, pharmaceutical glaze*, polyethylene glycol*, pregelatinized starch*, silicon dioxide*, stearic acid*, talc*, titanium dioxide*.

*may contain

Questions or comments? 1-800-634-7680

205R Medique Medi-Phenyl Label

Collect Medi-Bucks
See inside flap for further details
Medique®
Medi-Phenyl
Phenylephrine 5 mg
Nasal Decongestant
Descongestivo Nasal
Easy To Swallow
Film Coated Tablets
Facil de Tragar Tabletas con Cubierta Pelicular
Pull to Open
TiraParaAbrir
500 Tablets
(250 x 2)
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Untarias

205R Dover Sudanyl Label

Dover
Sudanyl PE
Nasal and Nasal Decongestant
Non-Drowsy, Sugar Free
Phenylephrine HCl 5 mg
Dover Pharmaceutical
Products of the highest quality and effectiveness
Tamper Resistant
Sealed Packets
Unit Dose Packs
500 Tablets
(250 Packets of 2)

MEDIQUE MEDI-PHENYL
phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-205
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
D&C RED NO. 27
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
TALC

Product Characteristics
Color	pink (pink)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	G;55
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:47682-205-33	100 PACKET (100 PACKET) in 1 BOX, UNIT-DOSE	contains a PACKET (47682-205-99)
1	NDC:47682-205-99	2 TABLET, FILM COATED (2 TABLET) in 1 PACKET	This package is contained within the BOX, UNIT-DOSE (47682-205-33)
2	NDC:47682-205-13	500 PACKET (500 PACKET) in 1 BOX, UNIT-DOSE	contains a PACKET (47682-205-99)
2	NDC:47682-205-99	2 TABLET, FILM COATED (2 TABLET) in 1 PACKET	This package is contained within the BOX, UNIT-DOSE (47682-205-13)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/30/2008	09/21/2010

DOVER SUDANYL PE
phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-323
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
D&C RED NO. 27
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
TALC

Product Characteristics
Color	pink (pink)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	G;55
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:47682-323-13	500 PACKET (500 PACKET) in 1 BOX, UNIT-DOSE	contains a PACKET (47682-323-99)
1	NDC:47682-323-99	2 TABLET, FILM COATED (2 TABLET) in 1 PACKET	This package is contained within the BOX, UNIT-DOSE (47682-323-13)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/30/2008	09/21/2010

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 01/2012 Unifirst First Aid Corporation