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  5. Label Information: Sinu-phen Plus Sinus Pain And Pressure

FDA Label for Sinu-phen Plus Sinus Pain And Pressure

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTHER
    6. DO NOT USE
    7. ASK DOCTOR
    8. ASK DOCTOR/PHARMACIST
    9. WHEN USING
    10. STOP USE
    11. PREGNANCY OR BREAST FEEDING
    12. KEEP OUT OF REACH OF CHILDREN
    13. DOSAGE & ADMINISTRATION
    14. OTHER SAFETY INFORMATION
    15. INACTIVE INGREDIENT
    16. QUESTIONS
    17. PRINCIPAL DISPLAY PANEL – 250 TABLET BOX LABEL

Sinu-phen Plus Sinus Pain And Pressure Product Label

The following document was submitted to the FDA by the labeler of this product Wildman Business Group. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Other



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 59°-86°F (15°-30°C)
  • 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

    Figure - sin0e 0000 01

    Figure - sin0e 0000 01


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