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. 

Active Ingredient

Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

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 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

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. 

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

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
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 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