MCKESSON PHENYLEPHRINE HCL- phenylephrine hcl tablet, film coated

McKesson Phenylephrine HCl by

Drug Labeling and Warnings

McKesson Phenylephrine HCl by is a Otc medication manufactured, distributed, or labeled by McKesson Medical-Surgical, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Phenylephrine HCl 5mg

PURPOSE

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

WARNINGS

Warnings

DO NOT USE

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 DOCTOR

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

When using this product

• do not exceed recommended dosage

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

• do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets every 4-6 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years:

Ask a doctor

OTHER SAFETY INFORMATION

Other information

• store at room temperature 59º-86º F (15º-30º C).
• tamper evident sealed packets.
• do not use any opened or torn packets

INACTIVE INGREDIENT

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

Questions or comments? Call 1-800-777-4908

PRINCIPAL DISPLAY PANEL

McKesson

Phenylephrine Tablets

NDC: 68599-1631-3

Phenylephrine HCl 5 mg

Pseudoephrine-free relief of nasal congestion due to the common cold.

2 Per Pack

250 Packs Per Box

MFR # 82479

INGREDIENTS AND APPEARANCE

MCKESSON PHENYLEPHRINE HCL 
phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-1631
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 68599-1631-3	250 in 1 BOX	09/01/2022	08/31/2027
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 Drug	M012	09/01/2022	08/31/2027

Labeler - McKesson Medical-Surgical (023904428)

Registrant - Unifirst First Aid Corporation (832947092)