ULINE SINUS AND CONGESTION- phenylephrine hydrochloride tablet, film coated

Uline Sinus and Congestion by

Drug Labeling and Warnings

Uline Sinus and Congestion by is a Otc medication manufactured, distributed, or labeled by Uline, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 5mg

Purpose

Nasal decongestant

Use

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.

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.
• 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?

1-800-295-5510

Uline Sinus & Congestion Label

ULINE

Tamper evident sealed packets:

Do not use if packet is open or torn.

Sinus & Congestion

Pull to Open

Phenylephrine HCl 5mg

Nasal Decongestant

50 Packets

2 tablets Each

INGREDIENTS AND APPEARANCE

ULINE SINUS AND CONGESTION 
phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69790-161(NDC:47682-161)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	271
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69790-161-33	50 in 1 BOX	10/07/2019
1		2 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	10/07/2019

Labeler - Uline (039612668)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(69790-161) , repack(69790-161)