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  5. Label Information: First Aid Direct Headache And Congestion Sinus Relief

FDA Label for First Aid Direct Headache And Congestion Sinus Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. OTHER SAFETY INFORMATION
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PRINCIPAL DISPLAY PANEL - 42961-126-02

First Aid Direct Headache And Congestion Sinus Relief Product Label

The following document was submitted to the FDA by the labeler of this product Cintas Corporation. 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.

Otc - Active Ingredient



Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg


Otc - Purpose



Purpose

Pain reliever/fever reducer

Nasal decongestant


Indications & Usage



Uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: 

  • sinus congestion and pressure
  • headache
  • minor aches and pains
  • nasal congestion
  • promotes sinus drainage
  • 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
  • adult has 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. 


Otc - 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.
  • 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Otc - Ask Doctor



Ask a doctor before use if you have 

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

Otc - Ask Doctor/Pharmacist



Ask a doctor before use if you are taking the blood thining drug warfarin. 


Otc - Stop Use



Stop use and ask doctor if

  • nervousness, dizziness, or sleplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

    • These could be signs of a serious condition. 


Otc - Pregnancy Or Breast Feeding



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


Otc - 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 (1-800-222-1222) right away. 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 older: • take 2 tablets every 6 hours • do not take more than 8 tablets in 24 hours
  • children under 12 years of age: ask a doctor

Other Safety Information



Other information

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

Inactive Ingredient



Inactive ingredients

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


Otc - Questions



Questions?

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


Principal Display Panel - 42961-126-02



HEADACHE & CONGESTION

SINUS RELIEF

Active Ingredients:

Acetaminophen • Phenylephrine HCl

Pain Reliever/Fever Reducer & Nasal Decongestant

  • Fast acting relief for nasal and sinus congestion
  • Helps reduce sinus pain, pressure, fever, and pain

    • 50 Tablets • 25 Packets (2 Tablets in each packet) per Box

    Box_Image - Box Image

    Box_Image - Box Image


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