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

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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:

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

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

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:

The Provision

First Aid

Line™

BY WILDMAN

250 tablets

2 Per Packet

Figure
SINU-PHEN PLUS   SINUS PAIN AND PRESSURE
acetaminophen, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84269-2546
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint Code AZ;261
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84269-2546-2125 in 1 BOX07/01/2024
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:84269-2546-150 in 1 BOX07/01/2024
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/01/2024
Labeler - Wildman Business Group (016677338)
Establishment
NameAddressID/FEIBusiness Operations
Allegiant Health079501930MANUFACTURE(84269-2546)
Establishment
NameAddressID/FEIBusiness Operations
Medique Products086911794PACK(84269-2546)
Establishment
NameAddressID/FEIBusiness Operations
Prestige Packaging080667761PACK(84269-2546)

Revised: 7/2024
Document Id: eefd29bb-ec15-45f6-9a43-22daf2a031b4
Set id: c66e0b52-5531-4a84-ae90-8a26d27df1ec
Version: 1
Effective Time: 20240701
 
Wildman Business Group