PHYSICIANSCARE SINUS NON-DROWSY- phenylephrine hcl tablet, film coated

PhysiciansCare Sinus by

Drug Labeling and Warnings

PhysiciansCare Sinus by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCL 10 mg

Purpose

Nasal decongestant

INDICATIONS & USAGE

Uses

Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

Promotes nasal and/or sinus drainage.

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

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

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

■ do not use more than directed

Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 doses 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

■ store at room temperature 59º-86º F (15º-30º C)

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive ingredients

croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

Questions or comments?

1-800-835-2263

PhysiciansCare Sinus Label

980087

Physicians Care®

Non-Drowsy Sinus

Decongestant Clears Sinus Pressure & Congestion

Pull To Open

Coated Tablets

Tamper-Evident Packets of 1 Tablet

Do not use if packet is open or torn.

Phenylephrine HCl 10mg

50 Tabletsts (50 Packets, 1tablet each)

INGREDIENTS AND APPEARANCE

PHYSICIANSCARE SINUS  NON-DROWSY
phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0133
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red (red)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	272
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0133-01	50 in 1 CARTON	01/29/2012
1	NDC: 0924-0133-00	1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-0133-03	10 in 1 CARTON	01/29/2012
2	NDC: 0924-0133-00	1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/29/2012

Labeler - Acme United Corporation (001180207)