First Aid Direct Headache And Congestion Sinus Relief

First Aid Direct Headache And Congestion Sinus Relief
SPL v3
SPL
SPL Set ID a518e124-5a96-4a08-9b5f-3eaa8bf944c0
Route
ORAL
Published
Effective Date 2025-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Phenylephrine (5 mg)
Inactive Ingredients
Starch, Corn Crospovidone Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-26
Description

Active ingredients (in each tablet) Acetaminophen 500 mg Phenylephrine HCl 5 mg

Medication Information

Warnings and Precautions

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. 

Indications and 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
Dosage and 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
Description

Active ingredients (in each tablet) Acetaminophen 500 mg Phenylephrine HCl 5 mg

Section 50565-1

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.

Section 50566-9

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. 

Section 50568-5

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

Section 50569-3

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
Section 50570-1

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.
Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions?

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

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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. 

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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. 

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions?

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Section 60561-8 (60561-8)

Other information

  • store at room temperature between 20-25°C (68-77°F)
  • do not use if packet is open or torn
Principal Display Panel 42961 126 02 (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:05.951886 · Updated: 2026-03-14T23:10:18.112618