FIRST AID DIRECT NASAL AND SINUS DECONGESTANT- phenylephrine hcl tablet

First Aid Direct Nasal and Sinus Decongestant by

Drug Labeling and Warnings

First Aid Direct Nasal and Sinus Decongestant by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

PURPOSE

Purpose

Nasal decongestant

INDICATIONS & USAGE

Uses

• temporarily relieves sinus congestion and pressure
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

WARNINGS

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 dose

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or occur with a 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 (1-800-222-1222) right away. 

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years and over:

• 1 tablet every 4 hours
• do not take more than 6 tablets in 24 hours

Children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

• store at room temperature 20°-25°C (68°-77°F)
• do not use if packet is opened or torn

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or comments?

Call 1-800-327-2704 M-F 8AM-5PM

Principal Display Panel - 25 CT Box

NASAL & SINUS DECONGESTANT 

• Compare to active ingredients in SUDAFED PE® Sinus Congestion*
• Helps to temporarily relieve: sinus congestion and pressure, nasal congestion due to the common cold, hay fever or other upper respiratory allergies 

25 Tablets  1 Tablet per Packet

NASAL & SINUS DECONGESTANT

Active Ingredient:

Phenylephrine HCl 10 mg

• Compare to active ingredients in SUDAFED PE® Sinus Congestion*
• Aspirin-free formula

25 Tablet  1 Tablet per Packet

Product #112350

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT NASAL AND SINUS DECONGESTANT 
phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-125
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-125-02	25 in 1 BOX	08/09/2023
1	NDC: 42961-125-01	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	08/09/2023

Labeler - Cintas Corporation (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	manufacture(42961-125)