First Aid Direct Headache And Congestion Sinus Relief
FDA Label NDC 42961-126

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product First Aid Direct Headache And Congestion Sinus Relief (NDC 42961-126). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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