SINU-PHEN PLUS SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet

Sinu-Phen Plus by

Drug Labeling and Warnings

Sinu-Phen Plus by is a Otc medication manufactured, distributed, or labeled by Wildman Business Group, Allegiant Health, Medique Products, Prestige Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

PURPOSE

Purpose

Pain reliever/fever reducer

Nasal decongestant

INDICATIONS & USAGE

Uses

temporarily relieves these common cold/flu symptoms:

• nasal congestion
• headache
• minor aches and pains
• stuffy nose
• sinus congestion and pressure temporarily reduces fever

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

DO NOT USE

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.
• for more than 10 days unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if you have

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

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
• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms appear

These could be signs of a serious condition.

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.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

OTHER SAFETY INFORMATION

Other information

• store at room temperature 59º-86ºF (15º-30ºC)
• tamper evident sealed packets
• do not use any opened or torn packets
• avoid excessive heat and humidity

INACTIVE INGREDIENT

Inactive ingredients

corn starch, crospovidone, hypromelloses, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

QUESTIONS

Questions or comments? (888) 602-0288

PRINCIPAL DISPLAY PANEL – 250 Tablet Box Label

Sinu-Phen Plus

Sinus Pain & Pressure

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Pull to Open

Fast Relief of:

• Fever
• Nasal Congestion
• Body Aches
• Sinus Pain

The Provision

First Aid

Line™

BY WILDMAN

250 tablets

2 Per Packet

INGREDIENTS AND APPEARANCE

SINU-PHEN PLUS   SINUS PAIN AND PRESSURE
acetaminophen, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84269-2546
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	AZ;261
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84269-2546-2	125 in 1 BOX	07/01/2024
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 84269-2546-1	50 in 1 BOX	07/01/2024
2		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	07/01/2024

Labeler - Wildman Business Group (016677338)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	MANUFACTURE(84269-2546)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	PACK(84269-2546)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	PACK(84269-2546)